We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Immatics NV | NASDAQ:IMTX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 10.81 | 10.32 | 11.29 | 0 | 01:00:00 |
☐ |
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ |
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
Ordinary shares, nominal value €0.01 per share |
IMTX |
The Nasdaq Stock Market | ||
Warrants to purchase ordinary shares |
IMTXW |
The Nasdaq Stock Market |
Large accelerated filer |
☐ |
Accelerated filer |
☐ | |||
Non-accelerated filer | ☒ |
Emerging growth company |
☒ |
U.S. GAAP ☐ |
International Financial Reporting Standards as issued |
Other ☐ | ||||||
by the International Accounting Standards Board |
☒ |
Page |
||||
1 | ||||
1 | ||||
1 | ||||
1 | ||||
1 | ||||
1 | ||||
1 | ||||
1 | ||||
1 | ||||
1 | ||||
1 | ||||
1 | ||||
66 | ||||
66 | ||||
66 | ||||
114 | ||||
114 | ||||
115 | ||||
115 | ||||
116 | ||||
123 | ||||
126 | ||||
126 | ||||
127 | ||||
128 | ||||
128 | ||||
134 | ||||
146 | ||||
148 | ||||
148 | ||||
148 | ||||
148 | ||||
150 | ||||
151 | ||||
151 | ||||
151 | ||||
152 | ||||
152 | ||||
152 | ||||
152 | ||||
152 | ||||
152 | ||||
152 | ||||
152 | ||||
152 | ||||
152 | ||||
153 | ||||
153 |
Page |
||||
153 | ||||
153 | ||||
173 | ||||
173 | ||||
173 | ||||
174 | ||||
174 | ||||
175 | ||||
175 | ||||
175 | ||||
175 | ||||
175 | ||||
176 | ||||
176 | ||||
176 | ||||
176 | ||||
176 | ||||
176 | ||||
176 | ||||
177 | ||||
177 | ||||
177 | ||||
177 | ||||
178 | ||||
178 | ||||
178 | ||||
178 | ||||
178 | ||||
179 | ||||
179 | ||||
180 | ||||
180 | ||||
180 |
• | the commencement, timing, progress and results of our research and development programs, preclinical studies and clinical trials, including our Adoptive Cell Therapy (“ACT”) and bispecific T cell engaging receptor (“TCR Bispecific”) trials; |
• | the timing of investigational new drug application (“IND”) or clinical trial application (“CTA”), biologics license application (“BLA”), Marketing Authorization Application (“MAA”) and other regulatory submissions with the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”) or comparable regulatory authorities; |
• | the proposed clinical development pathway for our product candidates and the acceptability of the results of clinical trials for regulatory approval of such product candidates by the FDA, the EMA or comparable regulatory authorities; |
• | assumptions relating to the identification of serious adverse, undesirable or unacceptable side effects related to our product candidates; |
• | the timing of and our ability to obtain and maintain regulatory approval for our product candidates; |
• | the potential advantages and differentiated profile of ACT and TCER Bispecific product candidates compared to existing therapies for the applicable indications; |
• | our ability to successfully manufacture or have manufactured drug product for clinical trials and commercialization; |
• | our expectations regarding the size of the patient populations amenable to treatment with our product candidates, if approved; |
• | assumptions relating to the rate and degree of market acceptance of any approved product candidates; |
• | the pricing and reimbursement of our product candidates; |
• | our ability to identify and develop additional product candidates; |
• | the ability of our competitors to discover, develop or commercialize competing products before or more successfully than we do; |
• | our competitive position and the development of and projections relating to our competitors or our industry; |
• | our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; |
• | our ability to raise capital when needed in order to continue our research and development programs or commercialization efforts; |
• | our ability to identify and successfully enter into strategic collaborations or licensing opportunities in the future, and our assumptions regarding any potential revenue that we may generate thereunder; |
• | our ability to obtain, maintain, protect and enforce intellectual property protection for our product candidates, and the scope of such protection; |
• | our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of third parties; |
• | our expectations regarding the impact of the COVID-19 pandemic; |
• | our expectations regarding geo-political actions and conflict, war and terrorism, including the recent conflict between Russia and Ukraine and resulting sanctions, retaliatory measures, changes in the availability and price of various materials and effects on global financial markets; |
• | our ability to attract and retain qualified key management and technical personnel; and |
• | our expectations regarding the time during which we will be an emerging growth company under the Jumpstart our Business Startups Act of 2012 (“JOBS Act”) and a foreign private issuer. |
ITEM 1. |
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS |
ITEM 2. |
OFFER STATISTICS AND EXPECTED TIMETABLE |
ITEM 3. |
KEY INFORMATION |
• | We have a history of operating losses and expect to continue to incur losses and will need additional capital to fund our operations and complete the development and commercialization of our product candidates. |
• | Our product candidates represent novel approaches to the treatment of diseases, and there are many uncertainties regarding the development of our product candidates. |
• | Our current product candidates are in various stages of development, and it is possible that none of our product candidates will ever become commercial products. |
• | Delays in the commencement and completion of clinical trials could increase costs and delay or prevent regulatory approval and commercialization of our product candidates. |
• | Clinical trials are expensive, time-consuming and difficult to design and implement, and our clinical trial costs may be higher than for more conventional therapeutic technologies or drug products. |
• | Our product candidates may cause undesirable side effects or have other properties that may delay or prevent their development or regulatory approval or limit their commercial potential. |
• | The regulatory review and approval processes of the FDA, the EMA and comparable regulatory authorities are lengthy, time-consuming and uncertain. If we are unable to obtain, or if there are delays in obtaining, regulatory approval for our product candidates, we will not be able to commercialize our product candidates and our ability to generate revenue will be materially impaired. |
• | The regulatory landscape that will govern our product candidates is still evolving. Regulations relating to more established gene therapy and cell therapy products and TCR Bispecific products are still developing, and changes in regulatory requirements could result in delays or discontinuation of development of our product candidates or unexpected costs in obtaining regulatory approval. |
• | Our product candidates are complex and difficult to manufacture. We could experience manufacturing problems that result in delays in our development or commercialization programs. |
• | We rely on third parties to conduct preclinical studies and/or clinical trials of our product candidates. If they do not properly and successfully perform their obligations to us, we may not be able to obtain regulatory approvals for our product candidates. |
• | We rely on third parties for the manufacture of our product candidates. Our dependence on these third parties may impair the clinical advancement and commercialization of our product candidates. |
• | We face substantial competition, which may result in others discovering, developing or commercializing products, treatment methods and/or technologies before or more successfully than we do. |
• | progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture ACT and TCR Bispecific product candidates for our ongoing, planned and potential future clinical trials; |
• | time and cost to conduct IND- or CTA-enabling studies for our preclinical programs; |
• | time and costs required to perform research and development to identify and characterize new product candidates from our research programs; |
• | 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; |
• | our ability to successfully commercialize our product candidates, if approved; |
• | our ability to have clinical and commercial products successfully manufactured consistent with FDA, the EMA and comparable regulatory authorities’ regulations; |
• | 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; |
• | sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities; |
• | cost of building, staffing and validating our manufacturing processes, which may include capital expenditure; |
• | terms and timing of our current and any potential future collaborations, licensing or other arrangements that we have established or may establish; |
• | cash requirements of any future acquisitions or the development of other product candidates; |
• | costs of operating as a public company; |
• | time and cost necessary to respond to technological, regulatory, political and market developments; |
• | costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and |
• | costs associated with any potential business or product acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish. |
• | negative preclinical data; |
• | delays in receiving the required regulatory clearance from the appropriate regulatory authorities to commence clinical trials or amend clinical trial protocols, including any objections to our INDs or CTAs or protocol amendments from regulatory authorities; |
• | delays in reaching, or a failure to reach, a consensus with regulatory authorities on study design; |
• | delays in reaching, or a failure to reach, an agreement on acceptable terms with prospective independent clinical investigators, CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different investigators, CROs and clinical trial sites; |
• | difficulties in obtaining required Institutional Review Board (“IRB”) or ethics committee approval at each clinical trial site; |
• | challenges in recruiting and enrolling suitable patients that meet the study criteria to participate in clinical trials; |
• | the inability to enroll a sufficient number of patients in clinical trials to ensure adequate statistical power to detect statistically significant treatment effects; |
• | imposition of a clinical hold by regulatory authorities or IRBs for any reason, including safety concerns and non-compliance with regulatory requirements; |
• | failure by independent clinical investigators, CROs, other third parties or us to adhere to clinical trial requirements; |
• | failure to perform in accordance with the FDA’s good clinical practices (“GCP”) or applicable regulatory guidelines in other jurisdictions; |
• | the inability to manufacture adequate quantities of a product candidate or other materials necessary in accordance with current Good Manufacturing Practices (“cGMPs”) and current Good Tissue Practices (“cGTPs”) to conduct clinical trials; |
• | lower than anticipated patient retention rates; |
• | difficulties in maintaining contact with patients after treatment, resulting in incomplete data; |
• | ambiguous or negative interim results; |
• | our independent clinical investigators, CROs or clinical trial sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a clinical trial; |
• | unforeseen safety issues, including occurrence of adverse events associated with the product candidate that are viewed to outweigh the product candidate’s potential benefits; |
• | changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; |
• | lack of adequate funding to continue the clinical trial; or |
• | delays and disruptions as a result of the COVID-19 pandemic. |
• | the size and nature of the patient population; |
• | the severity and incidence of the disease under investigation; |
• | the eligibility criteria for the study in question, including any misjudgment of, and resultant adjustment to, the appropriate ranges applicable to the exclusion and inclusion criteria; |
• | the size of the study population required for analysis of the trial’s primary endpoints; |
• | the ability to recruit clinical trial investigators with the appropriate competencies and experience; |
• | the number of clinical trial sites and the proximity of prospective patients to those sites; |
• | the design of the trial and the complexity for patients and clinical sites; |
• | the nature, severity and frequency of adverse side effects associated with our product candidates; |
• | the screening procedures and the rate of patients failing screening procedures; |
• | the ability to provide appropriate screening assays; |
• | the risk that patients’ general health conditions do not allow the conduct of study/screening procedures (for example, tumor biopsy, or leukapheresis) or application of lymphodepletion regimen; |
• | the ability to manufacture patient products appropriately (for example, at a sufficient high dose, or with sufficiently active T cells); |
• | the efforts to facilitate timely enrollment in clinical trials and the effectiveness of recruiting publicity; |
• | the patient referral practices of physicians within the same hospital as well as within other hospitals or private practices; |
• | competing clinical trials for similar therapies, other new therapeutics, new combination treatments, new medicinal products; |
• | approval of new indications for existing therapies or approval of new therapies in general or changes in standard of care; |
• | clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved or become standard of care for the indications we are investigating; |
• | the ability to obtain and maintain patient consents; and |
• | inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies, such as the COVID-19 pandemic. |
• | we may encounter delays or difficulties in enrolling patients for our clinical trials due to a negative perception of our product candidates’ safety and tolerability profile; |
• | we and/or regulatory authorities may temporarily or permanently put our clinical trials on hold; |
• | we may be unable to obtain regulatory approval for our product candidates; |
• | regulatory authorities may withdraw or limit their approvals of our product candidates; |
• | regulatory authorities may require the addition of labeling statements, such as a contraindication, boxed warnings or additional warnings; |
• | the FDA may require development of a Risk Evaluation and Mitigation Strategy with Elements to Assure Safe Use as a condition of approval; |
• | we may decide to remove our product candidates from the marketplace; |
• | we may be subject to regulatory investigations and government enforcement actions; |
• | we could be sued and held liable for harm caused to patients, including as a result of hospital errors; and |
• | our reputation may suffer. |
• | the FDA, the EMA or comparable regulatory authorities may disagree with the number, design or implementation of our clinical trials; |
• | the population studied in the clinical trial may not be considered sufficiently broad or representative to assure safety in the full population for which we seek approval; |
• | the FDA, the EMA or comparable regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials; |
• | the data collected from clinical trials of our product candidates may not meet the level of statistical or clinical significance required by the FDA, the EMA or comparable regulatory authorities or may otherwise not be sufficient to support the submission of a BLA, MAA or other submission or to obtain regulatory approval in the United States, the European Union or elsewhere; |
• | the FDA, the EMA or comparable regulatory authorities may not accept data generated by our preclinical service providers and clinical trial sites; |
• | the FDA, the EMA or comparable regulatory authorities may require us to conduct additional preclinical studies and clinical trials; |
• | the FDA, the EMA or comparable regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications applicable to the manufacture of our product candidates, the facilities of third-party manufacturers with which we contract for clinical or commercial supplies may fail to maintain a compliance status acceptable to the FDA, the EMA or comparable regulatory authorities or the EMA or comparable regulatory authorities may fail to approve facilities of third-party manufacturers with which we contract for clinical and commercial supplies; |
• | we or any third-party service providers may be unable to demonstrate compliance with cGMPs and cGTPs to the satisfaction of the FDA, the EMA or comparable regulatory authorities, which could result in delays in regulatory approval or require us to withdraw or recall products and interrupt commercial supply of our products; |
• | the approval policies or regulations of the FDA, the EMA or comparable regulatory authorities may change in a manner rendering our clinical data insufficient for approval; or |
• | political factors surrounding the approval process, such as government shutdowns and political instability. |
• | additional foreign regulatory requirements; |
• | foreign exchange fluctuations; |
• | compliance with foreign manufacturing, customs, shipment and storage requirements; |
• | an inability to negotiate the terms of clinical trial agreements at arms’ length in countries where a template agreement for such trials is required by law; |
• | cultural differences in medical practice and clinical research; and |
• | diminished protection of intellectual property in some countries. |
• | the clinical trial(s) required to verify the predicted clinical benefit of a product candidate fails to verify such benefit or does not demonstrate sufficient clinical benefit to justify the risks associated with the product candidate; |
• | other evidence demonstrates that a product candidate is not shown to be safe or effective under the conditions of use; |
• | we fail to conduct any required post-marketing confirmatory clinical trial with due diligence; or |
• | we disseminate false or misleading promotional materials relating to the relevant product candidate. |
• | restrictions on the marketing or manufacturing of the product; |
• | withdrawal of the product from the market or voluntary or mandatory product recalls; |
• | fines, restitution or disgorgement of profits or revenues; |
• | warning or untitled letters; |
• | requirements to conduct post-marketing studies or clinical trials; |
• | holds on clinical trials; |
• | refusal by the FDA, the EMA or comparable regulatory authorities to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product license approvals; |
• | product seizure or detention; |
• | refusal to permit the import or export of products; and |
• | injunctions or the imposition of civil or criminal penalties. |
• | have staffing difficulties; |
• | fail to comply with contractual obligations; |
• | experience regulatory compliance issues; |
• | undergo changes in priorities or become financially distressed; or |
• | form relationships with other entities, some of which may be our competitors. |
• | may not perform their obligations as expected; |
• | may encounter production difficulties that could constrain the supply of the companion diagnostic; |
• | may encounter difficulties in obtaining regulatory approval; |
• | may have difficulties gaining acceptance of the use of the companion diagnostic in the clinical community; |
• | may not commit sufficient resources to the marketing and distribution of such product; and |
• | may terminate their relationship with us. |
• | the scope of rights granted under the license agreement and other interpretation-related issues; |
• | whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
• | our right to sublicense patent and other rights to third parties under collaborative development relationships; |
• | our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations; and |
• | the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by us, our licensors, and our collaborators. |
• | we may not be able to detect infringement of our issued patents; |
• | others may be able to develop products that are similar to our products or product candidates, or any future product candidates we may develop, but that are not covered by the claims of the patents that we may in-license in the future or own; |
• | we, or our current or future collaborators or license partners, might not have been the first to make the inventions covered by the issued patents or patent application that we may in-license in the future or own; |
• | we, or our current or future collaborators or license partners, might be found not have been the first to file patent applications covering certain of our or their inventions; |
• | others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; |
• | it is possible that the pending patent applications we may in-license in the future or own will not lead to issued patents; |
• | it is possible that there are prior public disclosures that could invalidate our patents, or parts of our patents, for which we are not aware; |
• | issued patents that we hold rights to may be held invalid or unenforceable, as a result of legal challenges by our competitors; |
• | issued patents may not have sufficient term or geographic scope to provide meaningful protection; |
• | our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; |
• | we may not develop additional proprietary technologies that are patentable; |
• | the patents of others may have an adverse effect on our business; and |
• | we may choose not to file a patent in order to maintain certain trade secrets, and a third party may subsequently file a patent covering such intellectual property. |
• | our available capital resources or capital constraints we experience; |
• | the rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators; |
• | our ability to identify and enroll patients who meet clinical trial eligibility criteria; |
• | our receipt of approvals by the FDA, the EMA and comparable regulatory authorities, and the timing thereof; |
• | other actions, decisions or rules issued by regulators; |
• | our ability to access sufficient, reliable and affordable supplies of materials used in the manufacture of our product candidates; |
• | our ability to manufacture and supply clinical trial materials to our clinical sites on a timely basis; |
• | the efforts of our collaborators with respect to the commercialization of our products; and |
• | the securing of, costs related to, and timing issues associated with, commercial product manufacturing as well as sales and marketing activities. |
• | The federal Anti-Kickback Statute, which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual |
for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. The federal Anti-Kickback Statute has also been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other hand. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection. |
• | Federal civil and criminal false claims laws, such as the False Claims Act (“FCA”), which can be enforced by private citizens through civil qui tam actions, and civil monetary penalty laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. For example, pharmaceutical companies have been prosecuted under the FCA in connection with their alleged off-label promotion of drugs, purportedly concealing price concessions in the pricing information submitted to the government for government price reporting purposes, and allegedly providing free product to customers with the expectation that the customers would bill federal healthcare programs for the product. In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. |
• | HIPAA, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services. |
• | HIPAA, as amended by HITECH, and their implementing regulations, which impose privacy, security and breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates that perform services for them that involve individually identifiable health information. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. |
• | Federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers. |
• | The federal transparency requirements under the Physician Payments Sunshine Act, created under the Health Care Reform Act, which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value provided to physicians, as defined by such law, and teaching hospitals and physician ownership and investment interests, including such ownership and investment interests held by a physician’s immediate family members. |
• | State and foreign laws that are analogous to each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by non-governmental third-party payors, including private insurers. |
• | State and foreign laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or to track and report gifts, compensation and other remuneration provided to physicians and other healthcare providers; state laws that require the reporting of marketing expenditures or drug pricing, including information pertaining to and justifying price increases; state and local laws that require the registration of pharmaceutical sales representatives; state laws that prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals; state laws that require the posting of information relating to clinical trials and their outcomes; and other federal, state and foreign laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure, and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus requiring additional compliance efforts. |
• | decreased demand for our product candidates or products that we may develop; |
• | injury to our reputation and significant negative media attention; |
• | withdrawal of clinical trial sites and/or study participants; |
• | significant costs to defend the related litigations; |
• | a diversion of management’s time and our resources to pursue our business strategy; |
• | substantial monetary awards to study participants or patients; |
• | product recalls, withdrawals or labeling, marketing or promotional restrictions; |
• | loss of revenue; |
• | the inability to commercialize our product candidates that we may develop; and |
• | a decline in the price of our securities. |
• | high acquisition costs; |
• | the need to incur substantial debt or engage in dilutive issuances of equity securities to pay for acquisitions; |
• | the potential disruption of our historical business and our activities under our collaboration agreements; |
• | the strain on, and need to expand, our existing operational, technical, financial and administrative infrastructure; |
• | our lack of experience in late-stage product development and commercialization; |
• | the difficulties in assimilating employees and corporate cultures; |
• | the difficulties in hiring qualified personnel and establishing necessary development and/or commercialization capabilities; |
• | the failure to retain key management and other personnel; |
• | the challenges in controlling additional costs and expenses in connection with and as a result of the acquisition; |
• | the need to write down assets or recognize impairment charges; |
• | the diversion of our management’s attention to integration of operations and corporate and administrative infrastructures; and |
• | any unanticipated liabilities for activities of or related to the acquired business or its operations, products or product candidates. |
• | differing regulatory requirements in non-U.S. countries; |
• | unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; |
• | differing standards for the conduct of clinical trials; |
• | increased difficulties in managing the logistics and transportation of storing and shipping product candidates produced in the United States or elsewhere and shipping the product candidate to patients in other countries; |
• | import and export requirements and restrictions; |
• | economic weakness, including inflation, or political instability in foreign economies and markets; |
• | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
• | foreign taxes, including withholding of payroll taxes; |
• | foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country; |
• | difficulties staffing and managing foreign operations; |
• | workforce uncertainty in countries where labor unrest is more common than in the United States or Germany; |
• | differing payor reimbursement regimes, governmental payors or patient self-pay systems, and price controls; |
• | potential liability under the FCPA or comparable foreign regulations; |
• | challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States or Germany; |
• | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
• | business interruptions resulting from geo-political actions and conflict, war and terrorism, including the recent conflict between Russia and Ukraine and resulting sanctions, retaliatory measures, changes in the availability and price of various materials and effects on global financial markets; and |
• | business interruptions resulting from natural disasters including earthquakes, typhoons, floods and fires. |
• | results and timing of preclinical studies and clinical trials of our product candidates; |
• | results of clinical trials of our competitors’ products; |
• | public concern relating to the commercial value or safety of any of our product candidates; |
• | our inability to adequately protect our proprietary rights, including patents, trademarks and trade secrets; |
• | our inability to raise additional capital and the terms on which we raise it; |
• | commencement or termination of any strategic collaboration or licensing arrangement; |
• | regulatory developments, including actions with respect to our products or our competitors’ products; |
• | actual or anticipated fluctuations in our financial condition and operating results; |
• | publication of research reports by securities analysts about us or our competitors or our industry; |
• | our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market; |
• | additions and departures of key personnel; |
• | strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy; |
• | the passage of legislation or other regulatory developments affecting us or our industry, including changes in the structure of healthcare payment systems; |
• | fluctuations in the valuation of companies perceived by investors to be comparable to us; |
• | sales of our securities by us, our insiders or our other shareholders; |
• | speculation in the press or investment community; |
• | announcement or expectation of additional financing efforts; |
• | changes in market conditions for biopharmaceutical stocks; and |
• | changes in general market and economic conditions. |
• | if any of our product candidates receives regulatory approval, the timing and the terms of such approval and market acceptance and demand for such product candidates; |
• | variations in the level of expense related to the ongoing development of our product candidates or research pipeline; |
• | results of clinical trials, or the addition or termination of clinical trials or funding support by us, or existing or future collaborators or licensing partners; |
• | our execution of any additional collaboration, licensing or similar arrangements, and the timing of payments we may make or receive under existing or future arrangements, or the termination or modification of any such existing or future arrangements; |
• | developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products; |
• | any intellectual property infringement lawsuit or any opposition, interference, cancellation or other intellectual-property-related proceeding in which we may become involved; |
• | additions and departures of key personnel; |
• | strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy; |
• | fluctuations in the price of our ordinary shares; |
• | regulatory developments affecting our product candidates or those of our competitors; and |
• | changes in general market and economic conditions. |
• | a provision that our directors can only be appointed on the basis of a binding nomination prepared by the Board or by one or more shareholders who individually or jointly represent at least 10% of our issued share capital, which can be overruled by a two-thirds majority of votes cast representing more than half of our issued share capital; |
• | a provision that our directors can only be dismissed by the general meeting by a two-thirds majority of votes cast representing more than half of our issued share capital, unless the dismissal was proposed by the Board, in which latter case a simple majority of votes cast would be sufficient; |
• | a requirement that certain matters, including an amendment of our articles of association, may only be resolved upon by our general meeting if proposed by the Board; and |
• | a provision implementing a staggered board, pursuant to which only one class of Directors, will be elected at each general meeting, with the other classes continuing for the remainder of their respective terms. |
• | the Board, in light of the circumstances at hand when the cooling-off period was invoked, could not reasonably have concluded that the relevant proposal or hostile offer constituted a material conflict with the interests of our company and its business; |
• | the Board cannot reasonably believe that a continuation of the cooling-off period would contribute to careful policy-making; or |
• | other defensive measures, having the same purpose, nature and scope as the cooling-off period, have been activated during the cooling-off period and have not since been terminated or suspended within a reasonable period at the relevant shareholders’ request (i.e., no ‘stacking’ of defensive measures). |
ITEM 4. |
INFORMATION ON THE COMPANY |
• | IMA203: |
• | IMA201 and IMA202: |
• | IMA401: co-fund U.S. development in exchange for enhanced U.S. royalty payments and/or to co-promote IMA401 in the U.S.. |
• | IMA402: pre-clinical models, we initiated GMP manufacturing development for the lead candidate and we anticipate production of the clinical GMP batch in 2022 and initiation of Phase 1 in 2023. |
• | IMA40X: |
• | Advance our pipeline of ACTengine product candidates through clinical development. TCR-T programs include three product candidates (IMA201, IMA202, IMA203) in Phase 1 clinical trials investigating safety, tolerability, biological and clinical activity in patients with various types of solid tumors. In November 2021, we reported interim data from the ongoing Phase 1 dose-escalation stage of these clinical trials. We showed biological activity, a manageable safety profile, and early signs of anti-tumor activity. For IMA203, we demonstrated objective responses in 62% of evaluable patients treated at intermediate dose levels. Three partial responses were confirmed thereafter. As a next step, we plan to complete the dose escalation phase of the trial, evaluate the objective response rate (“ORR”) and assess duration of response at target dose in three cohorts: IMA203 monotherapy; IMA203 combination with checkpoint inhibition; and monotherapy with our 2nd generation IMA203CD8 product candidate engaging both CD8 and CD4 cells. We also intend to complete dose escalation for the IMA201 and IMA202 trials and move our IMA204 preclinical product candidate towards CTA or IND. Upon completion of the dose escalation phase, we will reevaluate whether to continue pursing IMA202 and IMA201 as product candidates. Moreover, we continue to actively investigate multiple next-generation enhancement and combination strategies beyond CD8 co-transduction to render ACTengine T cells even more potent to combat solid tumors. |
• | Advance our preclinical TCR Bispecifics pipeline towards clinical application IND-enabling activities for IMA402 in 2022, targeting manufacturing of the clinical batch in 2H2022 and CTA submission in 1H2023. Moreover, we will continue development of IMA40X which is preclinical stage. |
• | Leverage the full potential of PRAME HLA-A*02:01 patient population that might benefit from an anti-PRAME therapy by developing an off-the-shelf HLA-A*02 by investigating new target-TCR pairs for PRAME epitopes binding to other HLA types. |
• | Further enhance our manufacturing capabilities. |
activity of IMA203, we will now evaluate our future manufacturing strategy including but not limited to building or acquiring a fully integrated in-house manufacturing facility to maintain full control over drug supply in the future. |
• | Leverage the full potential of strategic collaborations |
• | Strengthen our intellectual property portfolio. |
• | Enhance the competitive edge of our technology platforms. TCR-based therapies. After having demonstrated objective responses against the well-known cancer testis antigen PRAME, we now plan to leverage the full potential of our technology platforms by developing TCR-based therapeutics against novel, less described targets (such as COL6A3) with different risk benefit profiles in our proprietary pipeline and together with our partners. |
• | Extend the impact of immunotherapy through dual targeting of tumor cells and tumor stroma. multi-TCR-T Proof-of-concept multi-TCR-T, |
• |
Utilizing True Cancer Targets & Matching Right TCRs |
• |
Enhancing T Cell Characteristics to Improve Clinical Outcome |
• |
Targeting Tumor Protective Barriers in Addition to Tumor Cells |
• | Phase 1a – Dose Escalation: 0.04-0.06 x 109 / m2 , dose level 2: 0.12-0.18 x 109 / m2 , dose level 3: 0.20-0.48 x 109 / m2 and dose level 4: up to 1.2 x 109 / m2 ). The product candidate is infused after lymphodepleting chemotherapy to determine the RP2D. After a dose level is cleared, the subsequent patients will be treated on the next higher dose level until reaching the target dose. |
• | Phase 1b – Cohort A: IMA203 Monotherapy Dose Expansion: |
• | Phase 1b – Cohort B: IMA203 Checkpoint Inhibitor Combination: PD-1 immune checkpoint inhibitor and to evaluate the initial anti-tumor activity of the combinatorial approach, as measured by tumor response according to RECIST1.1 or irRECIST. We plan to treat up to 18 additional patients in this cohort. |
• | Phase 1b – Cohort C: IMA203CD8 Monotherapy: b co-receptor. We will also evaluate the initial anti-tumor activity, as measured by tumor response according RECIST1.1 or irRECIST. We plan to treat up to 24 patients in this cohort starting with slightly reduced dose levels compared to IMA203 target dose. |
1 |
Exploration of higher dose (DL5) planned; |
2 |
Demonstrated to be important for long term remission: Melenhorst et al. |
• | In the case of ACT, XCEPTOR either picks high-affinity TCRs from the natural repertoire or modestly enhances these TCRs, aiming for single-digit micromolar affinities mirroring naturally occurring TCR affinities in viral infections. Additionally, we could pursue engineering TCRs to address alpha/beta chain pairing and/or CD8 independency. |
• | In the case of TCR Bispecifics, affinity of the target TCR is required to be much higher to achieve functional activity, thus the naturally occurring, specific TCRs need to be strongly affinity maturated using yeast display. Stable, high-affinity single-chain TCR variable fragments (scTvs) are serving as building blocks for the generation of the TCER compound. |
• | Companies such as Adaptimmune, Gritstone, Immunocore, Adaptive Biotechnologies, pureMHC, BioNTech, and Genentech are also seeking to identify HLA targets. |
• | Companies such as Adaptimmune, Kite Pharma (a Gilead company), Tmunity, T-knife, Juno Therapeutics (a BMS company), GSK, 2seventybio, Medigene, BioNTech, PACT Pharma, T-scan Therapeutics, Ziopharm oncology are investigating novel autologous TCR-T therapeutics. Their TCR-T programs are partially directed against peptide targets derived from the same proteins but not necessarily against the same peptide target as used by us. |
• | Companies such as Immunocore, Amgen, Genmab, Eureka Therapeutics, Molecular Partners, Harpoon Therapeutics, MacroGenics, Abbvie and Roche are developing TCR Bispecific compounds or TCR mimetic antibodies. |
• | IMA201: Four issued patents in the U.S., four issued foreign patents in Australia, South Korea, Colombia and Morocco, 170 pending patent applications in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Algeria, Eurasia, Egypt, Europe, Hong Kong, Indonesia, Israel, India, Japan, South Korea, Mexico, Malaysia, Morocco, New Zealand, Peru, Philippines, Singapore, Thailand, Taiwan, the Ukraine, the U.S., Vietnam and South Africa as well as 4 International applications (PCT) and 2 US provisional applications relating to IMA201 (MAGEA4/8). These patents and patent applications, if issued, are expected to expire between 2037 and 2042, in each case without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. |
• | IMA202: Three issued patents in the U.S., forty-seven (47) issued foreign patents in Germany, Australia, Colombia, Algeria, Indonesia, Taiwan, and Europe (validated in 41 countries), 142 pending patent applications in Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, Eurasia, Egypt, Europe, Gulf |
Cooperation Council, Hong Kong, Israel, India, Japan, South Korea, Mexico, Malaysia, Morocco, New Zealand, Peru, Philippines, Singapore, Thailand, Taiwan, the Ukraine, the U.S., Vietnam and South Africa as well as 4 International applications (PCT) and 2 US provisional applications relating to IMA202 (MAGEA1). These patents and patent applications, if issued, are expected to expire between 2037 and 2042, in each case without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. |
• | IMA203: Four issued patents in the U.S., two issued foreign patents in Taiwan and Algeria, hundred-and-forty-five |
• | IMA204: Seven issued patents in the U.S., ninety (90) issued foreign patents in, Japan, Hong Kong, South Korea, Mexico, New Zealand, Taiwan, Algeria, South Africa and Europe (two European patents each validated in 40 countries), hundred-and-seventy-six |
• | IMA401: Four issued patents in the U.S., four issued foreign patents in Australia, South Korea, Colombia and Morocco, two-hundred-and-two |
• | IMA402: Four issued patents in the U.S., two issued foreign patents in Taiwan and Algeria, ninety-one (91) pending patent applications in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Germany, Eurasia, Egypt, Europe, Gulf Cooperation Council, Hong Kong, Indonesia, Israel, India, Japan, South Korea, Mexico, Malaysia, New Zealand, Peru, Philippines, Singapore, Thailand, Taiwan, the Ukraine, the U.S., Vietnam and South Africa as well as 4 International applications (PCT) and 2 US provisional applications relating to the clinical candidates for IMA402 (PRAME). These patents and patent applications, if issued, are expected to expire between 2038 and 2042, in each case without taking into account any possible patent term adjustment or extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. |
• | preclinical testing including laboratory tests, animal studies, and formulation studies, which must be performed in accordance with the FDA’s GLP regulations, as applicable; |
• | submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin; |
• | approval by an IRB representing each clinical site before each clinical trial may be initiated; |
• | performance of adequate and well-controlled human clinical trials to establish the safety, and efficacy of the product candidate for each proposed indication, in accordance with current GCP; |
• | preparation and submission to the FDA of a BLA for a biological product; |
• | FDA acceptance and substantive review of the BLA; |
• | review of the product candidate by an FDA advisory committee, where appropriate or if applicable; |
• | satisfactory completion of an FDA inspection of the manufacturing facility or facilities, including those of third parties, at which the product candidate or components thereof are manufactured to assess compliance with cGMP requirements and to assure that the facilities, methods, and controls are adequate to preserve the product’s identity, strength, quality, and purity; |
• | satisfactory completion of any FDA audits of clinical trial sites to assure compliance with GCP and the integrity of clinical data in support of the BLA; and |
• | securing FDA approval of the BLA to allow marketing of the new biological product. |
• | Phase 1 clinical trials are initially conducted in a limited population to test the product candidate for safety, including adverse effects, dose tolerance, absorption, metabolism, distribution, excretion, and pharmacodynamics in healthy humans or in patients. During Phase 1 clinical trials, information about the investigational biological product’s pharmacokinetics and pharmacological effects may be obtained to permit the design of well-controlled and scientifically valid Phase 2 clinical trials. |
• | Phase 2 clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, evaluate the efficacy of the product candidate for specific targeted indications, and determine dose tolerance and optimal dosage. |
• | Phase 3 clinical trials are undertaken within an expanded patient population to further evaluate dosage, provide substantial evidence of clinical efficacy, and further test for safety. A well-controlled, statistically robust Phase 3 trial may be designed to deliver the data that regulatory authorities will use to decide whether or not to license, and, if licensed, how to appropriately label a biologic. |
• | restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market, or product recalls; |
• | fines, warning letters, or holds on post-licensing clinical trials; |
• | refusal of the FDA to approve pending applications or supplements to licensed applications, or suspension or revocation of product licenses; |
• | product seizure or detention, or refusal to permit the import or export of products; or |
• | injunctions or the imposition of civil or criminal penalties. |
• | the applicant must complete an identified program of studies within a time period specified by the competent authority, the results of which form the basis of a reassessment of the benefit/risk profile; |
• | the medicinal product in question may be supplied on medical prescription only and may in certain cases be administered only under strict medical supervision, possibly in a hospital and in the case of a radiopharmaceutical, by an authorized person; and |
• | the package leaflet and any medical information must draw the attention of the medical practitioner to the fact that the particulars available concerning the medicinal product in question are as yet inadequate in certain specified respects. |
• | compliance with the European Union’s stringent pharmacovigilance or safety reporting rules must be ensured. These rules can impose post-authorization studies and additional monitoring obligations; |
• | the manufacturing of authorized medicinal products, for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the applicable EU laws, regulations and guidance, including Directive 2001/83/EC, Directive 2003/94/EC, Regulation (EC) No 726/2004 and the European Commission Guidelines for Good Manufacturing Practice. These requirements include compliance with EU cGMP standards when manufacturing medicinal products and active pharmaceutical ingredients, including the manufacture of active pharmaceutical ingredients outside of the EU with the intention to import the active pharmaceutical ingredients into the EU; and |
• | the marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward the prescribers of drugs and/or the general public, are strictly regulated in the EU notably under Directive 2001/83EC, as amended, and EU Member State laws. Direct-to-consumer |
Company |
Jurisdiction of Incorporation |
Percentage Ownership and Voting Interest |
||||
Immatics Biotechnologies GmbH |
Germany | 100 | % | |||
Immatics US, Inc. |
Delaware, United States | 100 | % |
• | The corporate headquarters are located at Paul-Ehrlich-Straße 15 in 72076 Tübingen. It comprises approximately 2,600 square meters of office space as well as research and laboratory space. It houses Operations, Immunology, TCR Discovery and Validation, TCR Engineering & Bispecifics, Immunomonitoring, Discovery, Companion Diagnostics and CMC. |
• | Our operations facility is approximately 1,050 square meters and is located at Aischbachstraße 1 in 72070 Tübingen. It houses Operations, HR, IT, Finance, Translational Development, Regulatory Affairs and Clinical Development. |
• | Our third facility is approximately 1,040 square meters and is located in Machtlfinger Straße 5-15 in 81379 Munich. It houses Intellectual Property, IT, Communications and Business Development. |
• | The administrative office is a 6,690 square foot facility located at 2201 West Holcombe, Houston, TX 77030, and houses Operations, Human Resources, Finance, Clinical Operations, Regulatory, Bioinformatics and Program Management. |
• | The research and laboratory facility is a 15,694 square foot facility located in the Life Science Plaza building at 2130 West Holcombe, Suite 1100, Houston, Texas 77030. The research and laboratory facility is comprised primarily of laboratory space, with limited office seating that houses CMC, Immunology, Biomarkers, Quality Assurance and Quality Control. Our sublease on the space will expire in August 2023. |
ITEM 4A. |
UNRESOLVED STAFF COMMENTS |
ITEM 5. |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS |
• | advancing the proprietary pipeline of product candidates focusing on ACTengine and TCR Bispecifics; |
• | enhancing ACT manufacturing capabilities; |
• | disrupting the tumor microenvironment through combination therapies, next-generation technologies and novel target classes; |
• | developing novel personalized multi-TCR-T |
• | maintaining and enhancing the competitive edge of our target and TCR technology platforms; |
• | leveraging existing collaborations with BMS, Genmab and GSK and establish additional value-maximizing strategic collaborations and |
• | expanding our intellectual property portfolio. |
• | after reviewing trial results, we or our collaborators may abandon projects previously believed to be promising; |
• | we, our collaborators, or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks; |
• | our potential products may not achieve the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved; |
• | manufacturers may not meet the necessary standards for the production of the product candidates or may not be able to supply the product candidates in a sufficient quantity; |
• | regulatory authorities may find that our clinical trial design or conduct does not meet the applicable approval requirements; and |
• | safety and efficacy results in various human clinical trials reported in scientific and medical literature may not be indicative of results we obtain in our clinical trials. |
Year ended December 31, |
||||||||
2021 |
2020 |
|||||||
(Euros in thousands, except share and per share data) |
||||||||
Revenue from collaboration agreements |
€ | 34,763 | € | 31,253 | ||||
Research and development expenses |
(87,574 | ) | (67,085 | ) | ||||
General and administrative expenses |
(33,808 | ) | (34,186 | ) | ||||
Other income |
325 | 303 | ||||||
|
|
|
|
|||||
Operating result |
(86,294 |
) |
(69,715 |
) | ||||
Financial income |
5,675 | 2,949 | ||||||
Financial expenses |
(1,726 | ) | (10,063 | ) | ||||
Change in fair value of warrant liabilities |
(10,990 | ) | 17,775 | |||||
Share listing expense |
— | (152,787 | ) | |||||
Financial result |
(7,041 |
) |
(142,126 |
) | ||||
|
|
|
|
|||||
Loss before taxes |
(93,335 |
) |
(211,841 |
) | ||||
Taxes on income |
— | — | ||||||
Net loss |
(93,335 |
) |
(211,841 |
) | ||||
|
|
|
|
|||||
Net loss per share – basic and diluted |
(1.48 |
) |
(4.40 |
) | ||||
Weighted average shares outstanding – basic and diluted |
62,912,921 | 48,001,228 |
Year ended December 31, |
||||||||
2021 |
2020 |
|||||||
(Euros in thousands) |
||||||||
Revenue from collaboration agreements: |
||||||||
Amgen |
€ | 10,228 | € | 4,865 | ||||
Genmab |
6,929 | 11,204 | ||||||
BMS |
13,138 | 11,489 | ||||||
GSK |
4,468 | 3,695 | ||||||
|
|
|
|
|||||
Total revenue from collaboration agreements |
€34,763 |
€31,253 |
||||||
|
|
|
|
Year ended December 31, |
||||||||
2021 |
2020 |
|||||||
(Euros in thousands) |
||||||||
Direct external research and development expenses by program: |
||||||||
ACT Programs |
€14,897 | € | 8,153 | |||||
TCR Bispecifics Programs |
6,679 | 5,166 | ||||||
Other programs |
3,114 | 2,857 | ||||||
|
|
|
|
|||||
Sub-total direct external expenses |
€24,690 |
€16,176 |
||||||
|
|
|
|
|||||
Indirect research and development expenses: |
||||||||
Personnel related (excluding share-based compensation) |
€25,543 | €17,912 | ||||||
Share-based compensation expense |
15,564 | 14,546 | ||||||
IP Expenses |
9,701 | 9,294 | ||||||
Facility and depreciation |
5,325 | 5,385 | ||||||
Other indirect expenses |
6,751 | 3,772 | ||||||
|
|
|
|
|||||
Sub-total indirect expenses |
€62,884 |
€50,909 |
||||||
|
|
|
|
|||||
Total research and development expenses |
€87,574 |
€67,085 |
||||||
|
|
|
|
Year ended December 31, |
||||||||
2021 |
2020 |
|||||||
(Euros in thousands) |
||||||||
Share-based compensation expense |
€ | 10,839 | € | 10,973 | ||||
Personnel related (excluding stock-based compensation) |
8,641 | 7,983 | ||||||
Professional and consulting fees |
6,805 | 9,918 | ||||||
Other external general and administrative expenses |
7,524 | 5,312 | ||||||
|
|
|
|
|||||
Total general and administrative expenses |
€ |
33,808 |
€ |
34,186 |
||||
|
|
|
|
Year ended December 31, |
||||||||
2021 |
2020 |
|||||||
(Euros in thousands) |
||||||||
Net cash provided by / (used in): |
||||||||
Operating activities |
€ | (81,784 | ) | € | (85,610 | ) | ||
Investing activities |
7,493 | (15,949 | ) | |||||
Financing activities |
(2,613 | ) | 207,883 | |||||
Total cash flow |
€ |
(76,904 |
) |
€ |
106,324 |
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 intellectual property rights; and |
15. | costs associated with any potential business or product acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish. |
ITEM 6. |
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES |
Name |
Age |
Position | ||
Harpreet Singh, Ph.D. | 47 | Chief Executive Officer | ||
Arnd Christ | 55 | Chief Financial Officer | ||
Cedrik Britten, M.D. | 47 | Chief Medical Officer | ||
Carsten Reinhardt, M.D., Ph.D. | 54 | Chief Development Officer | ||
Toni Weinschenk, Ph.D. | 49 | Chief Innovation Officer | ||
Rainer Kramer, Ph.D. | 58 | Chief Business Officer | ||
Steffen Walter, Ph.D. | 45 | Chief Technology Officer |
Name |
Age |
Term Served |
Year in which Term Expires |
Position | ||||
Harpreet Singh, Ph.D. | 47 | July 1, 2020 – Present | 2023 | Executive director and Chief Executive Officer | ||||
Peter Chambré | 66 | July 1, 2020 – Present | 2022 | Non-executive director and Chairman | ||||
Michael G. Atieh | 68 | July 1, 2020 – Present | 2024 | Non-executive director | ||||
Paul R. Carter | 61 | July 1, 2020 – Present | 2024 | Non-executive director | ||||
Eliot Forster, Ph.D. | 55 | September 14, 2020 – Present | 2023 | Non-executive director | ||||
Friedrich von Bohlen und Halbach, Ph.D. | 59 | June 17, 2021 – Present | 2023 | Non-executive director | ||||
Heather L. Mason | 61 | July 1, 2020 – Present | 2022 | Non-executive director | ||||
Adam Stone | 42 | July 1, 2020 – Present | 2023 | Non-executive director | ||||
Nancy Valente* | 63 | March 22, 2022-Present | 2023 | Temporary non-executive director |
* | Mrs. Valente has been appointed by our Board as a temporary non-executive director as of March 22, 2022 and has been nominated for appointment as a non-executive director at our annual general meeting to be held in 2022. If elected by our shareholders at our annual general meeting to be held in 2022, Ms. Valente would serve a term that expires at our annual general meeting in 2023. |
Country of Principal Executive Offices : The Netherlands | ||||||||
Foreign Private Issuer : Yes | ||||||||
Disclosure Prohibited under Home Country Law : Yes | ||||||||
Total Number of Directors : 8 |
||||||||
Part I: Gender Identity |
Female | Male | Non-Binary |
Did Not Disclose | ||||
1 | 7 | 0 | 0 | |||||
Part II: Demographic Background |
||||||||
Underrepresented individual in home country jurisdiction | ||||||||
LGBTQ+ | ||||||||
Did not disclose |
(Euros in thousands) (1) |
Harpreet Singh, Ph.D. |
All other executives |
||||||
Periodically-paid remuneration |
€ | 484 | € | 1,997 | ||||
Bonuses |
€ | 285 | € | 1,032 | ||||
Share-based compensation expense |
€ | 7,946 | € | 9,070 | ||||
Total compensation |
€ |
8,715 |
€ |
12,099 |
(1) |
Amounts paid in U.S. dollars have been converted to Euros using an average exchange rate for 2021 of 1.17893 to one U.S. dollar. |
(Euros in thousands) |
Peter Chambré |
Friedrich von Bohlen |
Michael G. Atieh |
Paul Carter |
Heather L. Mason |
Adam Stone |
Christoph Hettich |
Eliot Forster |
Total |
|||||||||||||||||||||||||||
Board compensation |
80 | 20 | 55 | 53 | 40 | 40 | 20 | 40 | 348 |
|||||||||||||||||||||||||||
Share-based compensation expense |
1,143 | 30 | 114 | 114 | 114 | 114 | — | 122 | 1,751 |
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Total board compensation |
1,223 |
51 |
169 |
167 |
154 |
154 |
20 |
162 |
2,099 |
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
Harpreet Singh, Ph.D. |
Performance-based options | June 30, 2020 | 1,598,000 options will vest quarterly until the options are fully vested if the performance condition shall be deemed satisfied in three equal tranches as follows: a) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $1.5 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date b) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $2.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date c) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to |
1,598,000 | 10.00 | June 30, 2030 |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
$3.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date | ||||||||||||||||
Service options | June 30, 2020 | 63,000 options vested as of March 31, 2022, and an additional 105,000 will vest quarterly thereafter until the options are fully vested | 168,000 | 10.00 | June 30, 2030 | |||||||||||
Matching Stock options | June 30, 2020 | 264,624 options vested fully as of July 31, 2021 | 264,624 | 10.00 | June 30, 2030 | |||||||||||
Converted Stock options III | June 30, 2020 | 15,470 options vested as of March 31, 2022, and an additional 15,469 will vest quarterly thereafter until the options are fully vested | 30,939 | 1.06 | July 1, 2027 | |||||||||||
Converted Stock options IV | June 30, 2020 | 72,686 options vested as of March 31, 2022, and an additional 72,685 will vest quarterly thereafter until the options are fully vested | 145,371 | 1.17 | January 1, 2028 | |||||||||||
Service options | December 17, 2020 | 63,000 options vested as of March 31, 2022, and an additional 105,000 will vest quarterly thereafter until the options are fully vested | 168,000 | 9.70 | December 17, 2030 | |||||||||||
Service options | December 9, 2021 | 168,000 options will vest quarterly until the options are fully vested | 168,000 | 11.00 | December 09, 2031 | |||||||||||
Arnd Christ |
Performance-based options | September 14, 2020 | 255,000 options will vest quarterly until the options are fully vested if the performance condition shall be deemed satisfied in three equal tranches as follows: a) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $1.5 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date |
255,000 | 10.00 | September 14, 2030 |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
b) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $2.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date c) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $3.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date |
||||||||||||||||
Service options | September 14, 2020 | 15,313 options vested as of March 31, 2022, and an additional 33,687 will vest quarterly thereafter until the options are fully vested | 49,000 | 10.00 | September 14, 2030 | |||||||||||
Service options | December 17, 2020 | 15,313 options vested as of March 31, 2022, and an additional 33,687 will vest quarterly thereafter until the options are fully vested | 49,000 | 9.70 | December 17, 2030 | |||||||||||
Service options | December 9, 2021 | 98,000 options will vest quarterly until the options are fully vested | 98,000 | 11.00 | December 9, 2031 | |||||||||||
Cedrik Britten, M.D. |
Performance-based options | June 30, 2020 | 255,000 options will vest quarterly until the options are fully vested if the performance condition shall be deemed satisfied in three equal tranches as follows: a) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to |
255,000 | 10.00 | June 30, 2030 |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
$1.5 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date b) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $2.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date |
||||||||||||||||
c) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $3.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date | ||||||||||||||||
Converted Stock options VI | June 30, 2020 | 47,165 options vested as of March 31, 2022, and an additional 47,164 will vest quarterly thereafter until the options are fully vested | 94,329 | 10.00 | June 1, 2030 | |||||||||||
Service options | December 17, 2020 | 18,375 options vested as of March 31, 2022, and an additional 30,625 will vest quarterly thereafter until the options are fully vested | 49,000 | 9.70 | December 17, 2030 | |||||||||||
Service options | December 9, 2021 | 98,000 options will vest quarterly until the options are fully vested | 98,000 | 11.00 | December 9, 2031 | |||||||||||
Carsten Reinhardt, M.D., Ph.D. |
Performance-based options | June 30, 2020 | 255,000 options will vest quarterly until the options are fully vested if the performance condition shall | 255,000 | 10.00 | June 30, 2030 |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
be deemed satisfied in three equal tranches as follows: a) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $1.5 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date b) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $2.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date |
||||||||||||||||
c) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $3.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date | ||||||||||||||||
Service options | June 30, 2020 | 18,375 options vested as of March 31, 2022, and an additional 30,625 will vest quarterly thereafter until the options are fully vested | 49,000 | 10.00 | June 30, 2030 | |||||||||||
Matching Stock options | June 30, 2020 | 165,748 options vested fully as of July 31, 2021 | 165,748 | 10.00 | June 30, 2030 | |||||||||||
Converted Stock options III | June 30, 2020 | 9,376 options vested as of March 31, 2022, and an additional 9,377 will vest quarterly thereafter until the options are fully vested | 18,753 | 1.06 | July 1, 2027 |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
Service options | December 17, 2020 | 18,375 options vested as of March 31, 2022, and an additional 30,625 will vest quarterly thereafter until the options are fully vested | 49,000 | 9.70 | December 17, 2030 | |||||||||||
Service options | December 9, 2021 | 98,000 options will vest quarterly until the options are fully vested | 98,000 | 11.00 | December 9, 2031 | |||||||||||
Rainer Kramer, Ph.D. |
Performance-based options | June 30, 2020 | 255,000 options will vest quarterly until the options are fully vested if the performance condition shall be deemed satisfied in three equal tranches as follows: a) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $1.5 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date b) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $2.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date c) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $3.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date |
255,000 | 10.00 | June 30, 2030 |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
Service options | June 30, 2020 | 18,375 options vested as of March 31, 2022, and an additional 30,625 will vest quarterly thereafter until the options are fully vested | 49,000 | 10.00 | June 30, 2030 | |||||||||||
Matching Stock options | June 30, 2020 | 120,676 options vested fully as of July 31, 2021 | 120,676 | 10.00 | June 30, 2030 | |||||||||||
Converted Stock options III | June 30, 2020 | 11,434 options vested as of March 31, 2022, and an additional 11,434 will vest quarterly thereafter until the options are fully vested | 22,868 | 1.06 | July 1, 2027 | |||||||||||
Service options | December 17, 2020 | 18,375 options vested as of March 31, 2022, and an additional 30,625 will vest quarterly thereafter until the options are fully vested | 49,000 | 9.70 | December 17, 2030 | |||||||||||
Service options | December 9, 2021 | 98,000 options will vest quarterly until the options are fully vested | 98,000 | 11.00 | December 9, 2031 | |||||||||||
Toni Weinschenk, Ph.D. |
Performance-based options | June 30, 2020 | 255,000 options will vest quarterly until the options are fully vested if the performance condition shall be deemed satisfied in three equal tranches as follows: | 255,000 | 10.00 | June 30, 2030 | ||||||||||
a) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $1.5 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date b) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $2.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
c) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $3.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date |
||||||||||||||||
Service options | June 30, 2020 | 18,375 options vested as of March 31, 2022, and an additional 30,625 will vest quarterly thereafter until the options are fully vested | 49,000 | 10.00 | June 30, 2030 | |||||||||||
Matching Stock options | June 30, 2020 | 68,070 options vested fully as of July 31, 2021 | 68,070 | 10.00 | June 30, 2030 | |||||||||||
Converted Stock options III | June 30, 2020 | 3,925 options vested as of March 31, 2022, and an additional 3,925 will vest quarterly thereafter until the options are fully vested | 7,850 | 1.06 | July 1, 2027 | |||||||||||
Service options | December 17, 2020 | 18,375 options vested as of March 31, 2022, and an additional 30,625 will vest quarterly thereafter until the options are fully vested | 49,000 | 9.70 | December 17, 2030 | |||||||||||
Service options | December 9, 2021 | 98,000 options will vest quarterly until the options are fully vested | 98,000 | 11.00 | December 9, 2031 | |||||||||||
Steffen Walter, Ph.D. |
Performance-based options | June 30, 2020 | 255,000 options will vest quarterly until the options are fully vested if the performance condition shall be deemed satisfied in three equal tranches as follows: a) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $1.5 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date |
255,000 | 10.00 | June 30, 2030 |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
b) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $2.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date |
||||||||||||||||
c) One third (1/3) of the Option Shares shall satisfy the Performance Condition upon the Company’s achievement of market capitalization equal to $3.0 billion prior to the Expiration Date, subject to the Optionee’s continuous Service Relationship through such date | ||||||||||||||||
Service options | June 30, 2020 | 18,375 options vested as of March 31, 2022, and an additional 30,625 will vest quarterly thereafter until the options are fully vested | 49,000 | 10.00 | June 30, 2030 | |||||||||||
Matching Stock options | June 30, 2020 | 76,604 options vested fully as of July 31, 2021 | 76,604 | 10.00 | June 30, 2030 | |||||||||||
Converted Stock options III | June 30, 2020 | 4,478 options vested as of March 31, 2022, and an additional 4,477 will vest quarterly thereafter until the options are fully vested | 8,955 | 1.06 | July 1, 2027 | |||||||||||
Service options | December 17, 2020 | 18,375 options vested as of March 31, 2022, and an additional 30,625 will vest quarterly thereafter until the options are fully vested | 49,000 | 9.70 | December 17, 2030 | |||||||||||
Service options | December 9, 2021 | 98,000 options will vest quarterly until the options are fully vested | 98,000 | 11.00 | December 9, 2031 | |||||||||||
Peter Chambré |
Service options | June 30, 2020 | 9,375 options vested as of March 31, 2022, and an additional 15,625 will vest quarterly thereafter until the options are fully vested | 25,000 | 10.00 | June 30, 2030 |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
Matching Stock options | June 30, 2020 | 211,974 options vested fully as of July 31, 2021 | 211,974 | 10.00 | June 30, 2030 | |||||||||||
Service options | December 9, 2021 | 15,000 options will vest quarterly until the options are fully vested | 15,000 | 11.00 | December 9, 2031 | |||||||||||
Adam Stone |
Service options | June 30, 2020 | 9,375 options vested as of March 31, 2022, and an additional 15,625 will vest quarterly thereafter until the options are fully vested | 25,000 | 10.00 | June 30, 2030 | ||||||||||
Service options | December 9, 2021 | 15,000 options will vest quarterly until the options are fully vested | 15,000 | 11.00 | December 9, 2031 | |||||||||||
Friedrich von Bohlen |
Service options | June 17, 2021 | 25,000 options will vest quarterly until the options are fully vested | 25,000 | 12.05 | June 17, 2031 | ||||||||||
Service options | December 9, 2021 | 15,000 options will vest quarterly until the options are fully vested | 15,000 | 11.00 | December 9, 2031 | |||||||||||
Heather L. Mason |
Service options | June 30, 2020 | 9,375 options vested as of March 31, 2022, and an additional 15,625 will vest quarterly thereafter until the options are fully vested | 25,000 | 10.00 | June 30, 2030 | ||||||||||
Service options | December 9, 2021 | 15,000 options will vest quarterly until the options are fully vested | 15,000 | 11.00 | December 9, 2031 | |||||||||||
Michael G. Atieh |
Service options | June 30, 2020 | 9,375 options vested as of March 31, 2022, and an additional 15,625 will vest quarterly thereafter until the options are fully vested | 25,000 | 10.00 | June 30, 2030 | ||||||||||
Service options | December 9, 2021 | 15,000 options will vest quarterly until the options are fully vested | 15,000 | 11.00 | December 9, 2031 | |||||||||||
Paul Carter |
Service options | June 30, 2020 | 9,375 options vested as of March 31, 2022, and an additional 15,625 will vest quarterly thereafter until the options are fully vested | 25,000 | 10.00 | June 30, 2030 | ||||||||||
Service options | December 9, 2021 | 15,000 options will vest quarterly until the options are fully vested | 15,000 | 11.00 | December 9, 2031 |
Beneficiary |
Type of options |
Grant date |
Vesting date (1) |
Number of options outstanding |
Strike price in USD |
Expiration date | ||||||||||
Eliot Forster |
Service options | September 14, 2020 | 9,375 options vested as of March 31, 2022, and an additional 15,625 will vest quarterly thereafter until the options are fully vested | 25,000 | 9.16 | September 13, 2020 | ||||||||||
Service options | December 9, 2021 | 15,000 options will vest quarterly until the options are fully vested | 15,000 | 11.00 | December 9, 2031 |
• | monitoring the independence of our independent registered public accounting firm; |
• | assuring the rotation of the audit partners (including the lead and concurring partners) as required by law; |
• | pre-approving all audit services and permitted non-audit services to be performed by our independent registered public accounting firm; |
• | making recommendations regarding the appointment or replacement of our independent registered public accounting firm; |
• | determining the compensation and oversight of the work of our independent registered public accounting firm (including resolution of disagreements between the Executive Committee and the independent auditors regarding financial reporting) for the purpose of preparing or issuing an audit report or related work; |
• | reviewing and discussing with the independent auditors and the executive officers our annual financial statements and related disclosures as well as critical accounting policies and practices used by us; |
• | reviewing all related person transactions for potential conflict of interest situations and voting with respect to all such transactions; |
• | supervising the integrity of our financial reporting and the effectiveness of our internal risk management and control systems; and |
• | establishing procedures for the receipt, retention and treatment of complaints received by the company regarding accounting, internal accounting controls or auditing matters. |
• | reviewing and approving the corporate goals and objectives relevant to the compensation of our Chief Executive Officer; |
• | evaluating the performance of our Chief Executive Officer in light of such goals and objectives and determining and approving the compensation of the Chief Executive Officer based on such evaluation; |
• | reviewing and approving the compensation of all other executive officers; |
• | reviewing and making recommendations to the Board regarding policies and procedures for the grant of equity-based awards; |
• | administering our incentive-based and equity-based compensation plans; |
• | retaining or obtaining the advice of outside compensation consultants, legal counsel or other advisers; |
• | reviewing and discussing with management which executive compensation information should be included in our annual proxy statement; and |
• | reviewing and, where appropriate, making recommendations with regard to the compensation of directors. |
• | recommending criteria for Board and committee membership; |
• | assessing the performance of individual executive directors, non-executive directors and committee members and reporting findings to the Board; |
• | developing a plan for the succession of executive directors and non-executive directors; |
• | supervising selection criteria and appointment procedures for executive officers other than the Chief Executive Officer; |
• | developing and recommending to the Board a set of corporate governance guidelines and periodically reviewing and reassessing the adequacy of such guidelines; and |
• | reviewing and discussing with management disclosure of the company’s corporate governance practices. |
ITEM 7. |
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS |
• | each person, or group of affiliated persons, known by us to beneficially own more than 5% of outstanding ordinary shares; |
• | each of our directors and executive officers; and |
• | all of our directors and executive officers as a group. |
Beneficial Owner |
Number of Ordinary Shares |
Percentage of Ordinary Shares |
||||||
Directors, Executive Officers and Persons Nominated to Serve in Such Positions |
||||||||
Harpreet Singh, Ph.D. |
746,021 | 1.2 | % | |||||
Arnd Christ |
30,626 | * | ||||||
Cedrik Britten, M.D. |
65,540 | * | ||||||
Carsten Reinhardt, M.D., Ph.D. |
319,655 | * | ||||||
Toni Weinschenk, Ph.D. |
180,343 | * | ||||||
Rainer Kramer, Ph.D. |
229,198 | * | ||||||
Steffen Walter, Ph.D. |
156,134 | * | ||||||
Peter Chambré |
327,336 | * | ||||||
Michael G. Atieh |
9,375 | * | ||||||
Paul R. Carter |
9,375 | * | ||||||
Eliot Forster, Ph.D. |
9,375 | * | ||||||
Friedrich von Bohlen und Halbach, Ph.D.. |
— | — | ||||||
Heather L. Mason |
9,375 | * | ||||||
Adam Stone(1) |
9,375 | * | ||||||
All directors and executive officers and persons nominated to serve in such positions as a group (14 persons) |
2,101,728 | 3.3 | % | |||||
5% or Greater Shareholders |
||||||||
ARYA Sciences Holdings(2) |
3,503,750 | 5.6 | % | |||||
dievini Hopp BioTech holding GmbH & Co. KG(3) |
17,202,355 | 27.3 | % | |||||
Baker Bros. Advisors LP(4) |
4,423,731 | 7.0 | % | |||||
Nantahala Capital Management, LLC(5) |
3,990,128 | 6.3 | % |
* | Indicates beneficial ownership of less than 1% of total outstanding ordinary shares. |
(1) | Does not include any ordinary shares indirectly owned by Adam Stone as a result of his membership interest in ARYA Sciences Holdings. |
(2) | This information is based on a Schedule 13G filed with the SEC on February 16, 2021 by ARYA Sciences Holdings, which reported shared voting and dispositive power over 3,503,750 ordinary shares. ARYA Sciences Holdings is governed by a board of directors, consisting of three individuals, each of whom has one vote. A majority of the board of directors is required to make voting and dispositive decisions regarding the ordinary shares. As such, none of the members of the board of directors of the ARYA Sciences Holdings is deemed to be a beneficial owner of the ordinary shares. The principal business address of ARYA Sciences Holdings is 51 Astor Place, 10th Floor, New York, NY 10003. |
(3) | This information is based on a Schedule 13G filed with the SEC on February 11, 2022 by dievini Hopp BioTech holding GmbH & Co. KG (“dievini”), DH-LT-Investments, (“DH-LT-Investments”), DH-Capital GmbH & Co. KG (“DH-Capital”), OH Beteiligungen GmbH & Co. KG (“OH Beteiligungen”), Dietmar Hopp, Oliver Hopp, Daniel Hopp, Prof. Dr. Friedrich von Bohlen und Halbach, Prof. Dr. Christof Hettich, and Dr. Mathias Hothum, which reported shared voting and dispositive power over 17,202,355 ordinary shares. dievini is the record holder of 16,476,073 shares and DH-LT Investments is the record holder of 726,282 shares, for which dievini has shared voting and dispositive power. DH-Capital, OH Beteiligungen, Dr. von Bohlen and Dr. Hettich are collectively the holders of 100% of the limited partner interest in dievini. DH-Capital and OH Beteiligungen each hold a 40% limited partner interest in dievini and therefore, control the voting and dispositive decisions of dievini together and may be deemed to beneficially own the shares held by dievini. Dietmar Hopp, Daniel Hopp and Oliver Hopp are the ultimate controlling persons of dievini, DH-Capital and OH Beteiligungen, and control the voting and investment decisions of |
the ultimate parent company of dievini and therefore, may be deemed to beneficially own the shares held by dievini by virtue of their status as controlling persons of dievini. The sole general partner of dievini with the authorization to represent is dievini Verwaltungs GmbH; however, 100% of the shares of dievini Verwaltungs GmbH are held by dievini so dievini Verwaltungs GmbH is not considered to have control over dievini. The managing directors of dievini Verwaltungs GmbH are Dietmar Hopp, Dr. von Bohlen, Dr. Hettich and Dr. Hothum. Voting and dispositive decisions made within dievini Verwaltungs GmbH regarding the securities held by dievini are made by at least two managing directors acting together; however, Dietmar Hopp is entitled to represent dievini Verwaltungs GmbH solely. Therefore, in their capacity as managing directors, Dietmar Hopp, Dr. von Bohlen, Dr. Hettich and Dr. Hothum share voting and dispositive power over the shares held by dievini, and may be deemed to beneficially own such shares held by dievini; however, each of Dietmar Hopp, Dr. von Bohlen, Dr. Hettich and Dr. Hothum disclaims beneficial ownership of the shares held by dievini except to the extent of their pecuniary interests therein. The principal business address of dievini, Dietmar Hopp, Dr. von Bohlen, Dr. Hettich and Dr. Hothum is c/o dievini Hopp BioTech holding GmbH & Co. KG, Johann-Jakob-Astor Straße 57, 69190 Walldorf, Germany. The principal business address of DH-Capital GmbH & Co. KG and OH Beteiligungen GmbH & Co. KG is Opelstraße 28, 68789 St. Leon-Rot, Germany. The principal business address of Oliver Hopp and Daniel Hopp is Johann-Jakob-Astor-Straße 59, 69190 Walldorf, Germany. |
(4) | This information is based on a Schedule 13G filed with the SEC on February 14, 2022 by Baker Bros. Advisors LP, Baker Bros. Advisors (GP) LLC, Felix J. Baker and Julian C. Baker, which reported sole voting and dispositive power over 4,423,731 ordinary shares, which is the aggregate number of ordinary shares held by Baker Brothers Life Sciences, L.P. and 667, L.P. (collectively, the “Funds”). The Funds’ respective general partners relinquished to Baker Bros. Advisors LP (the “Adviser”). Baker Bros. Advisors (GP) LLC (the “Adviser GP”), Felix J. Baker and Julian C. Baker as managing members of the Adviser GP, and the Adviser may be deemed to be beneficial owners of the ordinary shares held by the Funds. The principal business address of each of the foregoing persons and entities is 860 Washington Street, 3rd Floor New York, NY 10014. |
(5) | This information is based on a Schedule 13G filed with the SEC on February 14, 2022 by Nantahala Capital Management, LLC (“Nantahala”), Wilmot B. Harkey and Daniel Mack, which reported shared voting and dispositive power over 3,990,128 ordinary shares. Nantahala may be deemed to be the beneficial owner of 3,990,128 Shares held by funds and separately managed accounts under its control, and as the managing members of Nantahala, each of Messrs. Wilmot Harkey and Daniel Mack may be deemed to be a beneficial owner of the ordinary shares. The principal business address of each of the foregoing persons and entities is 130 Main St. 2nd Floor New Canaan, CT 06840. |
ITEM 8. |
FINANCIAL INFORMATION |
ITEM 9. |
THE OFFER AND LISTING |
ITEM 10. |
ADDITIONAL INFORMATION |
• | certain financial institutions; |
• | mutual funds and pension plans; |
• | U.S. expatriates and certain former citizens or long-term residents of the United States; |
• | dealers or traders in securities who use a mark-to-market |
• | persons holding ordinary shares or warrants as part of a hedging transaction, “straddle,” “hedge,” “conversion,” “synthetic security,” “constructive ownership transaction,” “constructive sale” or other integrated transaction for U.S. federal income tax purposes; |
• | persons whose “functional currency” for U.S. federal income tax purposes is not the U.S. dollar; |
• | tax-exempt entities (including private foundations) or government organizations; |
• | S corporations, partnerships, or other entities or arrangements classified as partnerships for U.S. federal income tax purposes; |
• | regulated investment companies or real estate investment trusts; |
• | trusts and estates; |
• | persons who acquired our ordinary shares or warrants pursuant to the exercise of any employee stock option or otherwise as compensation; |
• | persons holding our ordinary shares or warrants in connection with a trade or business, permanent establishment, or fixed base outside the United States; or |
• | persons who own (directly or through attribution) 10% or more (by vote or value) of our outstanding ordinary shares. |
• | at least 75% of its gross income is passive income (such as income from dividends, interest, rent, royalties and certain gains) (the “Income Test”); or |
• | at least 50% of its gross assets (determined on the basis of a quarterly average) is attributable to assets that produce passive income or are held for the production of passive income (the “Asset Test”). |
• | the excess distribution or gain will be allocated ratably over a U.S. Holder’s holding period for ordinary shares (or, under proposed Treasury regulations, warrants); |
• | the amount allocated to the taxable year of disposition, and any taxable year prior to the first taxable year in which we became a PFIC, will be treated as ordinary income; and |
• | the amount allocated to each other year will be subject to the highest tax rate in effect for that year for individuals or corporations, as appropriate, and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year. |
• | holders of our ordinary shares if such holders, and in the case of individuals, his or her partner or certain of their relatives by blood or marriage in the direct line (including foster children), have a substantial interest (aanmerkelijk belang) or deemed substantial interest ( fictief aanmerkelijk belang Wet inkomstenbelasting 2001 |
individuals, together with his or her partner (as defined in the Dutch Income Tax Act 2001, directly or indirectly, holds (i) an interest of 5% or more of the total issued and outstanding capital of that company or of 5% or more of the issued and outstanding capital of a certain class of shares of that company; or (ii) rights to acquire, directly or indirectly, such interest; or (iii) certain profit sharing rights in that company that relate to 5% or more of the company’s annual profits and/or to 5% or more of the company’s liquidation proceeds. A deemed substantial interest may arise if a substantial interest (or part thereof) in a company has been disposed of, or is deemed to have been disposed of, on a non-recognition basis; |
• | holders of our ordinary shares if the shares held by such holders qualify or qualified as a participation ( deelneming Wet op de vennootschapsbelasting 1969 paid-up share capital (or, in certain cases, in voting rights) qualifies as a participation. A holder may also have a participation if (a) such holder does not have a shareholding of 5% or more but a related entity (statutorily defined term) has a participation or (b) if the company in which the shares are held is a related entity (statutorily defined term); |
• | holders of our ordinary shares if such holder is an individual for whom the ordinary shares or any benefit derived from the ordinary shares is a remuneration or deemed to be a remuneration for (employment) activities performed by such holder or certain individuals related to such holder (as defined in the Dutch Income Tax Act 2001); and |
• | pension funds, investment institutions ( fiscale beleggingsinstellingen vrijgestelde beleggingsinstellingen |
• | distributions in cash or in kind, deemed and constructive distributions and repayments of paid-in capital not recognized for Dutch dividend withholding tax purposes; |
• | liquidation proceeds, proceeds of redemption of shares, or proceeds of the repurchase of shares by us or one of our subsidiaries or other affiliated entities to the extent such proceeds exceed the average paid-in capital of those shares as recognized for purposes of Dutch dividend withholding tax, unless in case of a repurchase, a particular statutory exemption applies; |
• | an amount equal to the par value of shares issued or an increase of the par value of shares, to the extent that it does not appear that a contribution, recognized for purposes of Dutch dividend withholding tax, has been made or will be made; and |
• | partial repayment of the paid-in capital, recognized for purposes of Dutch dividend withholding tax, if and to the extent that we have net profits (zuivere winst), unless the holders of shares have resolved in advance at a general meeting to make such repayment and the par value of the shares concerned has been reduced by an equal amount by way of an amendment of the Articles of Association. |
• | is considered to be resident ( gevestigd Regeling laagbelastende staten en niet-coöperatieve rechtsgebieden voor belastingdoeleinden |
• | has a permanent establishment located in a Listed Jurisdiction to which the ordinary shares are attributable; or |
• | holds the ordinary shares for the main purpose or one of the main purposes to avoid taxation for another person or entity and there is an artificial arrangement or transaction or a series of artificial arrangements or transactions; or |
• | is not considered to be the beneficial owner of the ordinary shares in its jurisdiction of residence because such jurisdiction treats another entity as the beneficial owner of the ordinary shares (a hybrid mismatch); or |
• | is not resident in any jurisdiction (also a hybrid mismatch); or |
• | is a reverse hybrid (within the meaning of Article 2(12) of the Dutch Corporate Income Tax Act 1969), if and to the extent (x) there is a participant in the reverse hybrid which is related ( gelieerd |
• | the ordinary shares are attributable to an enterprise from which the holder of such shares derives a share of the profit, whether as an entrepreneur (ondernemer) or as a person who has a co-entitlement to the net worth (medegerechtigd tot het vermogen) of such enterprise, without being a shareholder, as defined in the Dutch Income Tax Act 2001); or |
• | the holder of the ordinary shares is considered to perform activities with respect to such shares that go beyond ordinary asset management (normaal, actief vermogensbeheer) or derives benefits from the shares that are taxable as benefits from other activities (resultaat uit overige werkzaamheden). |
• | such holder does not have an interest in an enterprise or a deemed enterprise (as defined in the Dutch Income Tax Act 2001 and the Dutch Corporate Income Tax Act 1969) which, in whole or in part, is either effectively managed in the Netherlands or is carried out through a permanent establishment, a deemed permanent establishment or a permanent representative in the Netherlands and to which enterprise or part of an enterprise the ordinary shares are attributable; and |
• | in the event such holder is an individual, such holder does not carry out any activities in the Netherlands with respect to the ordinary shares that go beyond ordinary asset management ( normaal, actief vermogensbeheer resultaat uit overige werkzaamheden |
• | if the partner is a corporation, the dividend income will be subject to corporate income tax plus solidarity surcharge (see “Corporations” above); |
• | if the partner is a sole proprietor, the dividend income will be subject to the partial income rule (see “Sole Proprietors” above); and |
• | if the partner is a private individual, the dividend income will be subject to the flat tax rate (see “Private Individuals” above); unless the partnership is a (operative or deemed) commercial partnership in which case the partial income rule applies). |
• | If the partner is a corporation, the capital gains will be subject to corporate income tax plus solidarity surcharge (see above “Corporations”). Trade tax will be levied additionally at the level of the partner insofar as the relevant profit of the partnership is not subject to trade tax at the level of the partnership. |
However, with respect to both corporate income and trade tax, the 95%-exemption rule as described above applies. With regard to corporate partners, special regulations apply if they are held as trading portfolio assets by credit institutions, financial service institutions or financial enterprises within the meaning of the German Banking Act or life insurance companies, health insurance companies or pension funds, as described above. |
• | If the partner is a sole proprietor (individual), the capital gains are subject to the partial income rule (see above “Sole proprietors”). |
ITEM 11. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
ITEM 12. |
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES |
ITEM 13. |
DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES |
ITEM 14. |
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS |
ITEM 15. |
CONTROLS AND PROCEDURES |
• | clearly defined control processes, roles and segregation of duties within our business processes to ensure appropriate financial reporting |
• | clearly defined control processes, roles and segregation of duties within our IT general controls for information systems that are significant to the preparation of our consolidated financial statements |
• | re-designed the key processes including IT general controls and included significant measures to ensure an effective internal control over financial reporting |
• | developed internal testing and monitoring procedures over these controls |
• | trained our accounting and finance staff and hired financial reporting personnel to develop and implement appropriate internal controls and reporting procedures |
ITEM 16A. |
AUDIT COMMITTEE FINANCIAL EXPERTS |
ITEM 16B. |
CODE OF ETHICS |
ITEM 16C. |
PRINCIPAL ACCOUNTANT FEES AND SERVICES |
For the Years Ended December 31, |
||||||||
2021 |
2020 |
|||||||
(euro in thousands) |
||||||||
Audit Fees |
1,298 | 1,042 | ||||||
Audit-Related Fees |
— | — | ||||||
Tax Fees |
— | — | ||||||
All Other Fees |
— | — | ||||||
Total Fees |
1,298 | 1,042 |
ITEM 16D. |
EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES |
ITEM 16E. |
PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS |
ITEM 16F. |
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT |
ITEM 16G. |
CORPORATE GOVERNANCE |
• | Quorum Requirements one-third of the outstanding voting stock. |
• | Solicitation of Proxies |
• | Compensation Committee |
• | Nominating and Corporate Governance Committee |
• | Director Compensation |
• | Shareholder Approval |
ITEM 16H. |
MINE SAFETY DISCLOSURE |
ITEM 16I. |
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS |
ITEM 17. |
FINANCIAL STATEMENTS |
ITEM 18. |
FINANCIAL STATEMENTS |
ITEM 19. |
EXHIBITS |
* | Filed herewith. |
# | Indicates a management contract or any compensatory plan, contract or arrangement. |
† | Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(a)(6) and Item 601(b)(10). |
/s/ Dietmar Eglauer | /s/ ppa. Jens Rosenberger | |
Wirtschaftsprüfer | Wirtschaftsprüfer | |
(German Public Auditor) | (German Public Auditor) |
Notes |
As of |
|||||||||||
December 31, 2021 |
December 31, 2020 |
|||||||||||
(Euros in thousands) |
||||||||||||
Assets |
||||||||||||
Current assets |
||||||||||||
Cash and cash equivalents |
132,994 | 207,530 | ||||||||||
Other financial assets |
24 | 12,123 | 24,448 | |||||||||
Accounts receivable |
7 | 682 | 1,250 | |||||||||
Other current assets |
8 | 6,408 | 5,763 | |||||||||
|
|
|
|
|||||||||
Total current assets |
152,207 |
238,991 |
||||||||||
Non-current assets |
||||||||||||
Property, plant and equipment |
9 | 10,506 | 7,868 | |||||||||
Intangible assets |
10 | 1,315 | 914 | |||||||||
Right-of-use |
11 | 9,982 | 6,149 | |||||||||
Other non-current assets |
8 | 636 | 724 | |||||||||
|
|
|
|
|||||||||
Total non-current assets |
22,439 |
15,655 |
||||||||||
|
|
|
|
|||||||||
Total assets |
174,646 |
254,646 |
||||||||||
|
|
|
|
|||||||||
Liabilities and shareholders’ equity |
||||||||||||
Current liabilities |
||||||||||||
Provisions |
51 | 51 | ||||||||||
Accounts payable |
12 | 11,624 | 10,052 | |||||||||
Deferred revenue |
13 | 50,402 | 46,600 | |||||||||
Other financial liabilities |
17 | 27,859 | 16,869 | |||||||||
Lease liabilities |
11 | 2,711 | 1,881 | |||||||||
Other current liabilities |
15 | 2,501 | 2,025 | |||||||||
|
|
|
|
|||||||||
Total current liabilities |
95,148 |
77,478 |
||||||||||
Non-current liabilities |
||||||||||||
Deferred revenue |
13 | 48,225 | 85,475 | |||||||||
Lease liabilities |
11 | 7,142 | 4,306 | |||||||||
Other non-current liabilities |
68 | — | ||||||||||
|
|
|
|
|||||||||
Total non-current liabilities |
55,435 |
89,781 |
||||||||||
Shareholders’ equity |
||||||||||||
Share capital |
19 | 629 | 629 | |||||||||
Share premium |
565,192 | 538,695 | ||||||||||
Accumulated deficit |
(537,813 | ) | (444,478 | ) | ||||||||
Other reserves |
(3,945 | ) | (7,459 | ) | ||||||||
|
|
|
|
|||||||||
Total shareholders’ equity |
24,063 |
87,387 |
||||||||||
|
|
|
|
|||||||||
Total liabilities and shareholders’ equity |
174,646 |
254,646 |
||||||||||
|
|
|
|
Notes |
Year ended December 31, |
|||||||||||||||
2021 |
2020 |
2019 |
||||||||||||||
(Euros in thousands, except share and per share data) |
||||||||||||||||
Revenue from collaboration agreements |
13 | 34,763 | 31,253 | 18,449 | ||||||||||||
Research and development expenses |
(87,574 | ) | (67,085 | ) | (40,091 | ) | ||||||||||
General and administrative expenses |
(33,808 | ) | (34,186 | ) | (11,756 | ) | ||||||||||
Other income |
14 | 325 | 303 | 385 | ||||||||||||
Operating result |
(86,294 |
) |
(69,715 |
) |
(33,013 |
) | ||||||||||
Financial income |
16 | 5,675 | 2,949 | 790 | ||||||||||||
Financial expenses |
16 | (1,726 | ) | (10,063 | ) | (264 | ) | |||||||||
Change in fair value of warrant liabilities |
17 | (10,990 | ) | 17,775 | — | |||||||||||
Share listing expense |
17 | — | (152,787 | ) | — | |||||||||||
Financial result |
(7,041 |
) |
(142,126 |
) |
526 |
|||||||||||
Loss before taxes |
(93,335 |
) |
(211,841 |
) |
(32,487 |
) | ||||||||||
Taxes on income |
— | — | — | |||||||||||||
Net loss |
(93,335 |
) |
(211,841 |
) |
(32,487 |
) | ||||||||||
Attributable to: |
||||||||||||||||
Equity holders of the parent |
(93,335 |
) | (211,284 | ) | (31,571 | ) | ||||||||||
Non-controlling interest |
20 | — | (557 | ) | (916 | ) | ||||||||||
Net loss |
(93,335 |
) |
(211,841 |
) |
(32,487 |
) | ||||||||||
Net loss per share—basic and diluted |
(1.48 |
) |
(4.40 |
) |
(0.95 |
) | ||||||||||
Weighted average shares outstanding—basic and diluted |
62,912,921 | 48,001,228 | 33,093,838 |
Notes |
Year ended December 31, |
|||||||||||||||
2021 |
2020 |
2019 |
||||||||||||||
(Euros in thousands) |
||||||||||||||||
Net Loss |
(93,335 |
) |
(211,841 |
) |
(32,487 |
) | ||||||||||
Other comprehensive loss |
||||||||||||||||
Items that may be reclassified subsequently to profit or loss, net of tax |
||||||||||||||||
Currency translation differences from foreign operations |
3,514 | (6,689 | ) | (29 | ) | |||||||||||
|
|
|
|
|
|
|||||||||||
Total comprehensive loss for the period |
(89,821 |
) |
(218,530 |
) |
(32,516 |
) | ||||||||||
Attributable to: |
||||||||||||||||
Equity holders of the parent |
(89,821 | ) | (217,973 | ) | (31,600 | ) | ||||||||||
Non-controlling interest |
20 | — | (557 | ) | (916 | ) | ||||||||||
|
|
|
|
|
|
|||||||||||
Total comprehensive loss for the period |
(89,821 |
) |
(218,530 |
) |
(32,516 |
) | ||||||||||
|
|
|
|
|
|
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(Euros in thousands) |
||||||||||||
Cash flows from operating activities |
||||||||||||
Loss before taxation |
(93,335 |
) |
(211,841 |
) |
(32,487 |
) | ||||||
Adjustments for: |
||||||||||||
Interest income |
(133 | ) | (850 | ) | (790 | ) | ||||||
Depreciation and amortization |
5,260 | 4,424 | 3,858 | |||||||||
Interest expense |
566 | 289 | 170 | |||||||||
Share listing expense |
— | 152,787 | — | |||||||||
Equity settled share-based payment |
26,403 | 22,908 | 152 | |||||||||
MD Anderson compensation expense |
— | 45 | 700 | |||||||||
(Decrease) Increase in other liabilities resulting from share appreciation rights |
— | (2,036 | ) | 1,864 | ||||||||
Payment related to share-based compensation awards previously classified as equity-settled |
— | (4,322 | ) | — | ||||||||
Net foreign exchange differences |
554 | (4,477 | ) | 3 | ||||||||
Change in fair value of warrant liabilities |
10,990 | (17,775 | ) | — | ||||||||
Changes in : |
||||||||||||
Decrease (increase) in accounts receivable |
569 | (294 | ) | (563 | ) | |||||||
(Increase) in other assets |
(483 | ) | (1,600 | ) | (1,497 | ) | ||||||
(Decrease) increase in accounts payable and other current liabilities |
(31,784 | ) | (23,387 | ) | 98,937 | |||||||
Interest received |
175 | 808 | 790 | |||||||||
Interest paid |
(566 | ) | (289 | ) | (170 | ) | ||||||
|
|
|
|
|
|
|||||||
Net cash (used in)/provided by operating activities |
(81,784 |
) |
(85,610 |
) |
70,967 |
|||||||
|
|
|
|
|
|
|||||||
Cash flows from investing activities |
||||||||||||
Payments for property, plant and equipment |
(5,106 | ) | (7,420 | ) | (2,143 | ) | ||||||
Cash paid for investments in Other financial assets * |
(11,298 | ) | (58,087 | ) | (77,810 | ) | ||||||
Cash received from maturity of investments classified in Other financial assets * |
24,448 | 49,662 | 74,888 | |||||||||
Payments for intangible assets |
(551 | ) | (104 | ) | (91 | ) | ||||||
Proceeds from disposal of property, plant and equipment |
— | — | 97 | |||||||||
|
|
|
|
|
|
|||||||
Net cash (used in)/provided by investing activities |
7,493 |
(15,949 |
) |
(5,059 |
) | |||||||
|
|
|
|
|
|
|||||||
Cash flows from financing activities |
||||||||||||
Proceeds from issuance of shares to equity holders of the parent |
94 | 217,918 | — | |||||||||
Transaction cost deducted from equity |
— | (7,939 | ) | — | ||||||||
Payments for leases |
(2,707 | ) | (2,096 | ) | (1,862 | ) | ||||||
|
|
|
|
|
|
|||||||
Net cash (used in)/provided by financing activities |
(2,613 |
) |
207,883 |
(1,862 |
) | |||||||
|
|
|
|
|
|
|||||||
Net (decrease)/increase in cash and cash equivalents |
(76,904 |
) |
106,324 |
64,046 |
||||||||
|
|
|
|
|
|
|||||||
Cash and cash equivalents at beginning of period |
207,530 |
103,353 |
39,367 |
|||||||||
|
|
|
|
|
|
|||||||
Effects of exchange rate changes on cash and cash equivalents |
2,368 | (2,147 | ) | (60 | ) | |||||||
|
|
|
|
|
|
|||||||
Cash and cash equivalents at end of period |
132,994 |
207,530 |
103,353 |
|||||||||
|
|
|
|
|
|
* |
See Note 2 for details regarding the revision of prior period numbers as a result of a correction in presentation of cash paid for investments in Other financial assets and Cash received from maturity of investments classified in Other financial assets |
(Euros in thousands) |
Notes |
Share capital |
Share premium |
Accumulated deficit |
Other reserves |
Total equity (deficit) attributable to shareholders of the parent |
Non- controlling interest |
Total share- holders’ equity (deficit) |
||||||||||||||||||||||||
Balance as of January 1, 2019 |
1,164 |
190,793 |
(201,623 |
) |
(741 |
) |
(10,407 |
) |
1,236 |
(9,171 |
) | |||||||||||||||||||||
Other comprehensive loss |
— | — | — | (29 | ) | (29 | ) | — | (29 | ) | ||||||||||||||||||||||
Net loss |
— | — | (31,571 | ) | — | (31,571 | ) | (916 | ) | (32,487 | ) | |||||||||||||||||||||
Comprehensive loss for the year |
— |
— |
(31,571 |
) |
(29 |
) |
(31,600 |
) |
(916 |
) |
(32,516 |
) | ||||||||||||||||||||
Equity-settled tandem awards |
18 | — | 152 | — | — | 152 | — | 152 | ||||||||||||||||||||||||
MD Anderson compensation expense |
20 | — | — | — | — | — | 700 | 700 | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance as of December 31, 2019 |
1,164 |
190,945 |
(233,194 |
) |
(770 |
) |
(41,855 |
) |
1,020 |
(40,835 |
) | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance as of January 1, 2020 |
1,164 |
190,945 |
(233,194 |
) |
(770 |
) |
(41,855 |
) |
1,020 |
(40,835 |
) | |||||||||||||||||||||
Other comprehensive loss |
— | — | — | (6,689 | ) | (6,689 | ) | — | (6,689 | ) | ||||||||||||||||||||||
Net loss |
— | — | (211,284 | ) | — | (211,284 | ) | (557 | ) | (211,841 | ) | |||||||||||||||||||||
Comprehensive loss for the year |
— |
— |
(211,284 |
) |
(6,689 |
) |
(217,973 |
) |
(557 |
) |
(218,530 |
) | ||||||||||||||||||||
Reorganization |
3,19 | (833 | ) | 833 | — | — | — | — | — | |||||||||||||||||||||||
Issue of share capital |
||||||||||||||||||||||||||||||||
MD Anderson Share Exchange |
3,20 | 7 | 501 | — | — | 508 | (508 | ) | — | |||||||||||||||||||||||
PIPE Financing, net of transaction costs |
3, 19 | 104 | 89,973 | — | — | 90,077 | — | 90,077 | ||||||||||||||||||||||||
ARYA Merger, net of transaction costs |
3,19,17 | 180 | 237,864 | — | — | 238,044 | — | 238,044 | ||||||||||||||||||||||||
SAR conversion |
18 | 7 | (7 | ) | — | — | — | — | — | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Total issuance of share capital |
298 |
328,331 |
— |
— |
328,629 |
(508 |
) |
328,121 |
||||||||||||||||||||||||
Equity-settled share-based compensation |
18 | — | 22,908 | — | — | 22,908 | — | 22,908 | ||||||||||||||||||||||||
Payment related to share-based compensation awards previously classified as equity-settled |
18 | — | (4,322 | ) | — | — | (4,322 | ) | — | (4,322 | ) | |||||||||||||||||||||
MD Anderson milestone compensation expense |
20 | — | — | — | — | — | 45 | 45 | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance as of December 31, 2020 |
629 |
538,695 |
(444,478 |
) |
(7,459 |
) |
87,387 |
— |
87,387 |
|||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance as of January 1, 2021 |
629 |
538,695 |
(444,478 |
) |
(7,459 |
) |
87,387 |
— |
87,387 |
|||||||||||||||||||||||
Other comprehensive income |
— | — | — | 3,514 | 3,514 | — | 3,514 | |||||||||||||||||||||||||
Net loss |
— | — | (93,335 | ) | — | (93,335 | ) | — | (93,335 | ) | ||||||||||||||||||||||
Comprehensive income/(loss) for the year |
— |
— |
(93,335 |
) |
3,514 |
(89,821 |
) |
— |
(89,821 |
) | ||||||||||||||||||||||
Equity-settled share-based compensation |
18 | — | 26,403 | — | — | 26,403 | — | 26,403 | ||||||||||||||||||||||||
Share options exercised |
— | 94 | — | — | 94 | — | 94 | |||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance as of December 31, 2021 |
629 |
565,192 |
(537,813 |
) |
(3,945 |
) |
24,063 |
— |
24,063 |
|||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1. |
Group information |
2. |
Basis of presentation |
2.1 |
Going concern |
2.4 |
COVID-19 |
3. |
ARYA Merger |
• | The shareholders of Immatics Biotechnologies GmbH exchanged their interest for ordinary shares in the share capital of Immatics B.V. (“the Reorganization”). The Reorganization is accounted for as a recapitalization, with Immatics Biotechnologies GmbH being the accounting predecessor. The Reorganization resulted in a €0.8 million decrease in share capital and an offsetting increase in share premium. Subsequent to the Reorganization, Immatics B.V. was converted into Immatics N.V., after the share exchange of Immatics shareholders. |
• | ARYA merged into Immatics N.V., with former ARYA shareholders receiving one ordinary share of Immatics N.V. for each issued and outstanding ordinary share of ARYA and one warrant to purchase ordinary shares in Immatics N.V., for each issued and outstanding warrant to acquire ordinary shares in ARYA. The merger of ARYA constituted a transaction by Immatics N.V., which is accounted for within the scope of IFRS 2. |
• | Immatics N.V. raised an additional net €90.1 million in net equity proceeds through a private placement of ordinary shares with existing shareholders of Immatics, ARYA and other new investors (“PIPE Financing”). The PIPE Financing is treated as a capital contribution, which resulted in increases of €0.1 million and €90.0 million to share capital and share premium, respectively. |
4. |
Application of new and revised international financial reporting standards |
4.1 |
Application of new standards |
Standard/interpretation |
Effective date | |
Amendment to IFRS 16, ‘Leases’ – COVID-19 related rent concessions |
April 1, 2021 | |
Changes to IFRS 4 – Effective date of IFRS 9 for insurance companies |
January 1, 2021 | |
Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 and IFRS 16 – Interest rate benchmark reform – Phase 2 |
January 1, 2021 |
4.2 |
Assessment of potential impact of future standards, amendments to existing standards and interpretations |
Standard/interpretation |
Effective date |
Material effect expected on Immatics financial statements | ||
Amendments to IFRS 3, ‘Business combinations’, IAS 16,’ Property, plant and equipment’, and IAS 37 ‘Provisions, contingent liabilities and contingent assets’ |
January 1, 2022 |
No | ||
Annual Improvements 2018-2020 |
January 1, 2022 |
No | ||
IFRS 17, ‘Insurance contracts’ as amended in June 2020 by amendments to IFRS 17, Insurance Contracts |
January 1, 2023 |
No | ||
Amendments to IAS 1, ‘Presentation of financial statements’, on classification of liabilities |
January 1, 2023 |
No | ||
Amendments to IAS 1, ‘Presentation of financial statements’, IFRS Practice statement 2 and IAS 8,’ Accounting policies, changes in accounting estimates and errors’ |
January 1, 2023 |
No |
5. |
Summary of accounting policies applied by the Group for the annual reporting period ending December 31, 2021 |
5.1 |
Segment information |
5.2 |
Cash and cash equivalents |
5.3 |
Financial assets |
5.4 |
Property, plant and equipment |
Category |
Estimated useful life | |
Computer equipment |
1 – 10 years | |
Laboratory equipment |
1 – 15 years | |
Office equipment |
2 – 20 years |
5.5 |
Intangible assets |
Category |
Estimated useful life | |
Licenses |
5 – 30 years | |
Software |
1 – 5 years |
5.6 |
Research and development |
1. | salaries, benefits and other related costs, including stock-based compensation, for personnel engaged in research and development functions; |
2. | expenses incurred in connection with the preclinical development of our programs and clinical trials of our product candidates, including under agreements with third parties, such as consultants, contractors, academic institutions and contract research organizations; |
3. | the cost of manufacturing product candidates for use in clinical trials, including under agreements with third parties, such as, consultants and contractors; |
4. | laboratory costs; |
5. | leased facility costs, equipment depreciation and other expenses, which include direct and allocated expenses; and |
6. | intellectual property costs incurred in connection with filing and prosecuting patent applications as well as third-party license fees. |
5.7 |
Financial liabilities: Initial recognition and measurement |
5.8 |
Leases |
1. | fixed payments (including in-substance fixed payments), less any lease incentives received. |
2. | amounts expected to be payable by the Group under residual value guarantees. |
3. | the exercise price of a purchase option if the Group is reasonably certain to exercise that option; and |
4. | payments of penalties for terminating the lease, if the lease term reflects the Group exercising that option. |
1. | uses a build-up approach that starts with a risk-free interest rate adjusted for credit risk for leases held by Immatics, and |
2. | makes adjustments specific to the lease, including lease term, country, currency and security |
1. | the amount of the initial measurement of lease liability |
2. | any lease payments made at or before the commencement date less any lease incentives received |
3. | any initial direct costs, and |
4. | restoration costs. |
5.9 |
Revenue from collaboration agreements |
(i) | identify the contract(s) with a customer; |
(ii) | identify the performance obligations in the contract; |
(iii) | determine the transaction price; |
(iv) | allocate the transaction price to the performance obligations in the contract; and |
(v) | recognize revenue when (or as) the Group satisfies a performance obligation. |
5.10 |
Share-based payment |
5.11 |
Other income |
5.12 |
Foreign currency |
2021 |
2020 |
2019 |
||||||||||||||||||||||
Year-end rate |
Average rate |
Year-end rate |
Average rate |
Year-end rate |
Average rate |
|||||||||||||||||||
Euros per U.S. Dollar |
0.88292 | 0.84495 | 0.8149 | 0.8762 | 0.8902 | 0.8932 | ||||||||||||||||||
5.13 |
Fair value of financial instruments |
• |
in the principal market for the asset or liability or |
• |
in the absence of a principal market, in the most advantageous market for the asset or liability that is accessible by the Group. |
• |
Level 1 — Quoted (unadjusted) market prices in active markets for identical assets or liabilities. |
• |
Level 2 — Valuation techniques, for which the lowest level input that is significant to the fair value measurement is directly or indirectly observable. |
• |
Level 3 — Valuation techniques, for which the lowest level input that is significant to the fair value measurement is unobservable. |
5.14 |
Provisions |
5.15 |
Income Tax |
6. |
Significant accounting judgements, estimates and assumptions |
7. |
Accounts receivable |
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Receivables from collaboration agreements |
682 | 1,250 | ||||||
Accounts receivable |
682 |
1,250 |
||||||
8. |
Other current and non-current assets |
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Grant receivable |
762 | 875 | ||||||
Prepaid expenses |
3,781 | 2,389 | ||||||
Positive market value forward contract |
— | 914 | ||||||
Value added tax receivable |
915 | 798 | ||||||
Other assets |
950 | 787 | ||||||
Other current assets |
6,408 |
5,763 |
||||||
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Prepaid expenses |
636 | 724 | ||||||
Total non-current assets |
636 |
724 |
||||||
9. |
Property, plant and equipment |
(Euros in thousands) |
Laboratory equipment |
Computer equipment |
Office equipment |
Total |
||||||||||||
Cost as of January 1, 2020 |
12,723 |
2,956 |
1,753 |
17,432 |
||||||||||||
Additions |
3,545 | 406 | 1,427 | 5,379 | ||||||||||||
Disposals |
1 | — | 6 | 7 | ||||||||||||
Currency translation differences |
299 | 40 | 28 | 367 | ||||||||||||
Cost as of December 31, 2020 |
15,968 |
3,322 |
3,146 |
22,437 |
||||||||||||
Accumulated depreciation as of January 1, 2020 |
9,303 |
2,050 |
1,359 |
12,712 |
||||||||||||
Additions |
1,384 | 404 | 315 | 2,102 | ||||||||||||
Disposals |
1 | — | 6 | 7 | ||||||||||||
Currency translation differences |
210 | 26 | 3 | 239 | ||||||||||||
Accumulated depreciation as of December 31, 2020 |
10,476 |
2,428 |
1,665 |
14,568 |
||||||||||||
Net book value as of December 31, 2020 |
5,493 |
894 |
1,481 |
7,868 |
||||||||||||
Cost as of January 1, 2021 |
15,968 |
3,322 |
3,146 |
22,437 |
||||||||||||
Additions |
3,487 |
1,105 |
489 |
5,081 |
||||||||||||
Disposals |
144 |
— |
— |
144 |
||||||||||||
Currency translation differences |
319 |
43 |
26 |
388 |
||||||||||||
Cost as of December 31, 2021 |
19,630 |
4,470 |
3,661 |
27,761 |
||||||||||||
Accumulated depreciation as of January 1, 2021 |
10,476 |
2,428 |
1,665 |
14,568 |
||||||||||||
Additions |
1,501 |
508 |
565 |
2,574 |
||||||||||||
Disposals |
144 |
— |
— |
144 |
||||||||||||
Currency translation differences |
219 |
30 |
7 |
256 |
||||||||||||
Accumulated depreciation as of December 31, 2021 |
12,052 |
2,966 |
2,237 |
17,255 |
||||||||||||
Net book value as of December 31, 2021 |
7,578 |
1,504 |
1,424 |
10,506 |
||||||||||||
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(Euros in thousands) |
||||||||||||
Research and development expenses |
1,684 | 1,502 | 1,315 | |||||||||
General and administrative expenses |
890 | 600 | 482 | |||||||||
|
|
|
|
|
|
|||||||
Total |
2,574 |
2,102 |
1,797 |
|||||||||
|
|
|
|
|
|
10. |
Intangible assets |
(Euros in thousands) |
Patents and licenses |
Software licenses |
Total |
|||||||||
Cost as of January 1, 2020 |
1,220 |
643 |
1,863 |
|||||||||
Additions |
— | 104 | 104 | |||||||||
Currency translation differences |
(88 | ) | (9 | ) | (97 | ) | ||||||
|
|
|
|
|
|
|||||||
Cost as of December 31, 2020 |
1,132 |
738 |
1,870 |
|||||||||
Accumulated amortization as of January 1, 2020 |
369 |
486 |
855 |
|||||||||
Additions |
56 | 71 | 126 | |||||||||
Currency translation differences |
(22 | ) | (3 | ) | (25 | ) | ||||||
|
|
|
|
|
|
|||||||
Accumulated amortization as of December 31, 2020 |
403 |
554 |
957 |
|||||||||
|
|
|
|
|
|
|||||||
Net book value as of December 31, 2020 |
730 |
184 |
914 |
|||||||||
|
|
|
|
|
|
|||||||
Cost as of January 1, 2021 |
1,132 |
738 |
1,870 |
|||||||||
Additions |
320 | 162 | 481 | |||||||||
Currency translation differences |
99 | 8 | 107 | |||||||||
|
|
|
|
|
|
|||||||
Cost as of December 31, 2021 |
1,551 |
908 |
2,459 |
|||||||||
Accumulated amortization as of January 1, 2021 |
403 |
554 |
957 |
|||||||||
Additions |
54 | 106 | 160 | |||||||||
Currency translation differences |
23 | 4 | 27 | |||||||||
|
|
|
|
|
|
|||||||
Accumulated amortization as of December 31, 2021 |
480 |
664 |
1,144 |
|||||||||
|
|
|
|
|
|
|||||||
Net book value as of December 31, 2021 |
1,071 |
244 |
1,315 |
|||||||||
|
|
|
|
|
|
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(Euros in thousands) |
||||||||||||
Research and development expenses |
35 | 31 | 28 | |||||||||
General and administrative expenses |
125 | 95 | 83 | |||||||||
|
|
|
|
|
|
|||||||
Total |
160 |
126 |
111 |
|||||||||
|
|
|
|
|
|
11. |
Leases |
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Buildings |
9,028 | 5,760 | ||||||
Laboratory equipment |
669 | — | ||||||
IT and telecommunication |
177 | 258 | ||||||
Vehicles |
74 | 90 | ||||||
Other assets |
34 | 41 | ||||||
|
|
|
|
|||||
Total |
9,982 |
6,149 |
||||||
|
|
|
|
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Lease liability – current |
2,711 | 1,881 | ||||||
Lease liability – non-current |
7,142 | 4,306 | ||||||
|
|
|
|
|||||
Total |
9,853 |
6,187 |
||||||
|
|
|
|
Year ended December 31, |
||||||||
Depreciation charges of right-of-use |
2021 |
2020 |
||||||
(Euros in thousands) |
||||||||
Buildings |
2,199 | 2,036 | ||||||
Laboratory equipment |
162 | — | ||||||
IT and telecommunication |
98 | 101 | ||||||
Vehicles |
59 | 50 | ||||||
Other assets |
8 | 8 | ||||||
|
|
|
|
|||||
Total |
2,526 |
2,195 |
||||||
|
|
|
|
|||||
Interest expenses from leases |
288 |
260 |
||||||
Expense relating to short-term leases and low-value assets (included in administrative expense) |
95 |
51 |
12. |
Accounts payable |
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Accounts payable |
3,009 | 2,554 | ||||||
Other accrued liabilities |
8,615 | 7,498 | ||||||
|
|
|
|
|||||
Total accounts payable |
11,624 |
10,052 |
||||||
|
|
|
|
13. |
Revenue from collaboration agreements |
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Current |
50,402 | 46,600 | ||||||
Non-current |
48,225 | 85,475 | ||||||
Total |
98,627 |
132,075 |
||||||
14. |
Other income |
15. |
Other current liabilities |
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Payroll tax |
1,760 | 1,185 | ||||||
Accrual for vacation |
607 | 525 | ||||||
Accrued bonuses |
— | 154 | ||||||
Other |
134 | 161 | ||||||
|
|
|
|
|||||
Total |
2,501 |
2,025 |
||||||
|
|
|
|
16. |
Financial income and expenses |
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(Euros in thousands) |
||||||||||||
Interest income from short-term deposits |
133 | 850 | 790 | |||||||||
Foreign currency gains |
5,542 | — | — | |||||||||
Gain on other financial instruments |
— | 2,099 | — | |||||||||
|
|
|
|
|
|
|||||||
Financial income |
5,675 |
2,949 |
790 |
|||||||||
Interest expenses |
(566 | ) | (289 | ) | (170 | ) | ||||||
Foreign currency losses |
(276 | ) | (9,774 | ) | (94 | ) | ||||||
Losses on other financial instruments |
(884 | ) | — | — | ||||||||
|
|
|
|
|
|
|||||||
Financial expenses |
(1,726 |
) |
(10,063 |
) |
(264 |
) |
Description |
Amount |
Number of shares/warrants |
||||||
(a) ARYA Ordinary Shares |
— | 17,968,750 | ||||||
(b) Closing price of ARYA Ordinary Shares on Nasdaq as of July 1, 2020 |
€ | 13.53 | — | |||||
(c) Fair value of TopCo Shares issued to ARYA shareholders (a * b) |
€ | 243,071 | — | |||||
(d) Outstanding ARYA Warrants |
— | 7,187,500 | ||||||
(e) Closing price of ARYA Warrants on Nasdaq as of July 1, 2020 |
€ | 4.82 | — | |||||
(f) Fair value of outstanding ARYA Warrants (d * e) |
€ | 34,644 | — | |||||
(g) Cash and cash equivalents held in ARYA’s trust account |
€ | 128,849 | ||||||
(h) Current liabilities by ARYA |
€ | 3,921 | ||||||
ARYA’s identifiable net assets (g-f-h) |
€ | 90,284 | — | |||||
IFRS 2 Expense on the closing date |
€ |
152,787 | — |
December 31, |
||||||||
Amounts in USD |
2019 |
2018 |
||||||
Exercise price |
$ | 1.12 | $ | 1.12 | ||||
Underlying share price |
$ | 67.87 | $ | 27.21 | ||||
Volatility |
73 | % | 64 | % | ||||
Time period (years) |
1.25 | 5.00 | ||||||
Risk free rate |
1.59 | % | 2.77 | % | ||||
Dividend yield |
0.00 | % | 0.00 | % | ||||
Combined probability of exit events |
80.00 | % | 25.00 | % |
2019 |
2018 |
|||||||||||||||
Weighted average exercise price in USD |
Number |
Weighted average exercise price in USD |
Number |
|||||||||||||
SARs outstanding at January 1, |
$ | 1.12 | 43,675 | $ | 1.12 | 43,978 | ||||||||||
SARs granted |
— | — | ||||||||||||||
SARs forfeited |
1.12 | 220 | 1.12 | 303 | ||||||||||||
SARs outstanding at December 31, |
1.12 | 43,455 | 1.12 | 43,675 | ||||||||||||
SARs vested |
$ | 1.12 | 117 | $ | 1.12 | 169 | ||||||||||
SARs exercisable |
— | — |
2019 |
2018 |
|||||||||||||||
Weighted average exercise price in USD |
Number |
Weighted average exercise price in USD |
Number |
|||||||||||||
Tandem Awards outstanding at January 1, |
$ | 16.65 | 74,401 | $ | 16.65 | 31,880 | ||||||||||
Tandem awards granted in June to September |
18.30 | 26,557 | 16.65 | 43,964 | ||||||||||||
Tandem awards granted in December |
23.82 | 5,447 | ||||||||||||||
Tandem awards forfeited |
16.81 | 2,936 | 16.65 | 1,443 | ||||||||||||
Tandem awards outstanding at December 31, |
17.45 | 103,469 | 16.65 | 74,401 | ||||||||||||
Tandem awards vested |
$ | 16.76 | 16,238 | $ | 16.65 | 14,350 | ||||||||||
Tandem awards exercisable |
— | — | ||||||||||||||
Weighted average remaining contract life (years) |
8.56 | 9.12 | ||||||||||||||
Weighted average fair value of options granted in USD till September |
10.27 | 4.51 | ||||||||||||||
Weighted average fair value of options granted in USD for December |
53.41 | — |
Amounts in USD |
December 2019 |
June 2019 - September 2019 |
December 2018 |
|||||||||
Exercise price in USD |
$ | 23.82 | $ | 18.30 | $ | 16.65 | ||||||
Underlying share price in USD |
$ | 67.87 | $ | 16.94 | $ | 27.21 | ||||||
Volatility |
73 | % | 78 | % | 64 | % | ||||||
Time period (years) |
1.25 | 2.10 | 5.00 | |||||||||
Risk free rate |
1.59 | % | 2.04 | % | 2.77 | % | ||||||
Dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | ||||||
Combined probability of exit events |
80.00 | % | 60.00 | % | 25.00 | % |
As of June 30, 2020 |
||||
Exercise price in USD |
$ | 10.00 | ||
Underlying share price in USD |
$ | 15.15 | ||
Volatility |
75 | % | ||
Time period (years) |
5.5 | |||
Risk free rate |
0.29 | % | ||
Dividend yield |
0.00 | % |
2021 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
Matching Stock Options outstanding on January 1, |
10.00 | 1,422,556 | ||||||
Matching Stock Options forfeited |
10.00 | 9,254 | ||||||
Matching Stock Options exercised |
10.00 | 6,834 | ||||||
Matching Stock Options expired |
— | — | ||||||
Matching Stock Options outstanding on December 31, |
10.00 | 1,406,468 | ||||||
Matching Stock Options vested |
10.00 | 1,413,302 | ||||||
Weighted average remaining contract life (years) |
8.50 |
2020 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
Matching Stock Options outstanding on January 1, |
— |
— |
Matching Stock Options granted in June |
10.00 | 1,430,818 | |||||||
Matching Stock Options forfeited |
10.00 | 8,262 | |||||||
Matching Stock Options exercised |
— | — | |||||||
Matching Stock Options expired |
— | — | |||||||
Matching Stock Options outstanding on December 31, |
10.00 | 1,422,556 | |||||||
Matching Stock Options vested |
— | — | |||||||
Weighted average remaining contract life (years) |
9.50 | ||||||||
Weighted average fair value of options granted in USD for June |
10.59 |
As of June 30, 2020 |
||||
Average exercise price in USD |
$ | 2.47 | ||
Underlying share price in USD |
$ | 15.15 | ||
Volatility |
75 | % | ||
Time period (years) |
5.6 | |||
Risk free rate |
0.29 | % | ||
Dividend yield |
0.00 | % |
2021 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
Converted Options outstanding on January 1, |
2.58 | 594,844 | ||||||
Converted Options forfeited |
1.30 | 18,548 | ||||||
Converted Options exercised |
1.29 | 8,180 | ||||||
Converted Options expired |
1.29 | 1,805 | ||||||
Converted Options outstanding on December 31, |
2.64 | 566,311 | ||||||
Converted Options vested |
2.61 | 193,727 | ||||||
Weighted average remaining contract life (years) |
6.01 |
2020 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
Converted Options outstanding on January 1, |
— | — | ||||||
Converted Options granted in June |
2.49 | 632,384 | ||||||
Converted Options forfeited |
1.08 | 37,540 | ||||||
Converted Options exercised |
— | — | ||||||
Converted Options expired |
— | — | ||||||
Converted Options outstanding on December 31, |
2.58 | 594,844 | ||||||
Converted Options vested |
2.45 | 53,856 | ||||||
Weighted average remaining contract life (years) |
7.01 | |||||||
Weighted average fair value of options granted in USD for June |
4.83 |
As of March 30, 2021 |
As of June 17, 2021 |
As of June 29, 2021 |
As of September 28, 2021 |
|||||||||||||
Exercise price in USD |
$ | 11.68 | $ | 12.05 | $ | 11.93 | $ | 12.92 | ||||||||
Underlying share price in USD |
$ | 11.68 | $ | 12.05 | $ | 11.93 | $ | 12.92 | ||||||||
Volatility |
85.77 | % | 84.67 | % | 84.53 | % | 83.57 | % | ||||||||
Time period (years) |
6.11 | 6.11 | 6.11 | 6.11 | ||||||||||||
Risk free rate |
1.17 | % | 1.10 | % | 1.08 | % | 1.19 | % | ||||||||
Dividend yield |
0.00 | % | 0.00 | % | 0.00 | % | 0.00 | % |
As of September 29, 2021 |
As of October 27, 2021 |
As of December 9, 2021 |
||||||||||
Exercise price in USD |
$ | 12.75 | $ | 13.45 | $ | 11.00 | ||||||
Underlying share price in USD |
$ | 12.75 | $ | 13.45 | $ | 11.00 | ||||||
Volatility |
83.51 | % | 82.07 | % | 81.80 | % | ||||||
Time period (years) |
6.11 | 6.11 | 6.11 | |||||||||
Risk free rate |
1.19 | % | 1.34 | % | 1.29 | % | ||||||
Dividend yield |
0.00 | % | 0.00 | % | 0.00 | % |
As of June 30, 2020 |
As of September 14, 2020 |
As of December 17, 2020 |
||||||||||
Exercise price in USD |
$ | 10.00 | $ | 10.00 | $ | 9.70 | ||||||
Underlying share price in USD |
$ | 15.15 | $ | 9.16 | $ | 9.70 | ||||||
Volatility |
75 | % | 79 | % | 84 | % | ||||||
Time period (years) |
7.0 | 6.2 | 6.0 | |||||||||
Risk free rate |
0.29 | % | 0.37 | % | 0.49 | % | ||||||
Dividend yield |
0.00 | % | 0.00 | % | 0.00 | % |
2021 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
Service Options outstanding on January 1, |
9.87 | 1,910,182 | ||||||
Service Options granted in March, |
11.68 | 90,325 | ||||||
Service Options granted in June, |
11.97 | 75,980 | ||||||
Service Options granted in September, |
12.81 | 88,875 | ||||||
Service Options granted in October, |
13.45 | 53,324 | ||||||
Service Options granted in December, |
11.00 | 1,659,204 | ||||||
Service Options forfeited |
10.01 | 149,178 | ||||||
Service Options exercised |
10.00 | 3,093 | ||||||
Service Options expired |
— | — | ||||||
Service Options outstanding on December 31, |
10.57 | 3,725,619 | ||||||
Service Options vested |
9.86 | 557,401 | ||||||
Weighted average remaining contract life (years) |
9.36 |
2020 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
Service Options outstanding on January 1, |
— | — | ||||||
Service Options granted in June, |
10.00 | 1,087,417 | ||||||
Service Options granted in September, |
9.72 | 74,000 | ||||||
Service Options granted in December, |
9.70 | 802,149 | ||||||
Service Options forfeited |
10.00 | 53,384 | ||||||
Service Options exercised |
— | — | ||||||
Service Options expired |
— | — | ||||||
Service Options outstanding on December 31, |
9.87 | 1,910,182 | ||||||
Service Options vested |
— | — | ||||||
Weighted average remaining contract life (years) |
9.72 |
As of September 28, 2021 |
||||
Exercise price in USD |
$ | 12.92 | ||
Underlying share price in USD |
$ | 12.92 | ||
Volatility |
77.16 | % | ||
Time period (years) |
3.75 | |||
Risk free rate |
1.49 | % | ||
Dividend yield |
0.00 | % |
As of June 30, 2020 |
As of September 14, 2020 |
|||||||
Exercise price in USD |
$ | 10.00 | $ | 10.00 | ||||
Underlying share price in USD |
$ | 15.15 | $ | 9.16 | ||||
Volatility |
79 | % | 78 | % | ||||
Time period (years) |
7.0 | 6.7 | ||||||
Risk free rate |
0.66 | % | 0.67 | % | ||||
Dividend yield |
0.00 | % | 0.00 | % |
2021 |
||||||||
Weighted average exercise price in USD |
Number |
PSUs outstanding on January 1, |
10.00 | 3,644,000 | ||||||
PSUs granted in September |
12.92 | 100,000 | ||||||
PSUs forfeited |
10.00 | 48,000 | ||||||
PSUs outstanding on December 31, |
10.08 | 3,696,000 | ||||||
PSUs vested |
— | — | ||||||
Weighted average remaining contract life (years) |
8.98 |
2020 |
||||||||
Weighted average exercise price in USD |
Number |
|||||||
PSUs outstanding on January 1, |
— | — | ||||||
PSUs granted in June |
10.00 | 3,644,000 | ||||||
PSUs granted in September |
10.00 | 255,000 | ||||||
PSUs forfeited |
10.00 | 255,000 | ||||||
PSUs outstanding on December 31, |
10.00 | 3,644,000 | ||||||
PSUs vested |
— | — | ||||||
Weighted average remaining contract life (years) |
9.60 |
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(Euros in thousands) |
Research and development expenses |
15,564 | 14,546 | 1,556 | |||||||||
General and administrative expenses |
10,839 | 10,973 | 460 |
Total share-based compensation |
26,403 |
25,519 |
2,016 |
|||||||||
19. |
Shareholders’ equity (deficit) |
20. |
Non-controlling interests |
21. |
Personnel expenses |
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(Euros in thousands) |
||||||||||||
Wages and salaries |
||||||||||||
Research and development expenses |
21,993 | 15,277 | 11,635 | |||||||||
General and administrative expenses |
7,105 | 6,968 | 3,596 | |||||||||
Total Wages and salaries |
29,098 |
22,245 |
15,231 |
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(Euros in thousands) |
||||||||||||
Other employee benefits |
||||||||||||
Research and development expenses |
3,550 | 2,624 | 2,035 | |||||||||
General and administrative expenses |
1,536 | 1,015 | 728 | |||||||||
Total other employee benefits |
5,086 |
3,639 |
2,763 |
|||||||||
Share-based compensation expense |
||||||||||||
Research and development expenses |
15,564 | 14,546 | 1,556 | |||||||||
General and administrative expenses |
10,839 | 10,973 | 460 | |||||||||
Total share-based compensation expense |
26,403 |
25,519 |
2,016 |
|||||||||
Total |
60,587 |
51,403 |
20,010 |
|||||||||
22. |
Income Tax |
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(Euros in thousands) |
||||||||||||
Loss before tax |
(93,335 | ) | (211,841 | ) | (32,487 | ) | ||||||
Expected tax benefit |
27,160 | 61,646 | 9,454 | |||||||||
Effects |
||||||||||||
Difference in tax rates |
(3,274 | ) | (2,582 | ) | (1,875 | ) | ||||||
Non-deductible tax-expenses |
(53 | ) | (599 | ) | (61 | ) | ||||||
Government grants exempted from taxes |
— | 45 | 8 | |||||||||
Permanent Differences |
(10,881 | ) | (39,288 | ) | — | |||||||
Non-recognition of deferred taxes on tax losses and temporary differences |
(12,953 | ) | (19,222 | ) | (7,526 | ) | ||||||
Taxes on income |
— |
— |
— |
|||||||||
As of |
||||||||||||||||
December 31, 2021 |
December 31, 2020 |
|||||||||||||||
(Euros in thousands) |
||||||||||||||||
Deferred tax assets |
Deferred tax liabilities |
Deferred tax assets |
Deferred tax liabilities |
|||||||||||||
Intangible assets |
1,288 | — | 1,770 | — | ||||||||||||
Right-of-use |
— | (2,629 | ) | — | (1,713 | ) | ||||||||||
Deferred revenue |
— | — | 180 | — | ||||||||||||
Other liabilities |
— | — | — | — | ||||||||||||
Lease liability |
2,627 | — | 1,776 | — | ||||||||||||
Deferred expenses |
12 | — | 3 | — | ||||||||||||
Recognized |
3,927 | (2,629 | ) | 3,729 | (1,713 | ) | ||||||||||
Netting |
(2,629 | ) | 2,629 | (1,713 | ) | 1,713 | ||||||||||
Non-recognition due to history of losses |
(1,298 | ) | — | (2,016 | ) | — | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net tax |
— |
— |
— |
— |
||||||||||||
|
|
|
|
|
|
|
|
23. |
Financial Risk Management Objectives and Policies |
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Cash and cash equivalents |
10,410 | 42,528 | ||||||
Financial assets |
— | — | ||||||
|
|
|
|
|||||
Total assets exposed to the risk |
10,410 |
42,528 |
||||||
|
|
|
|
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Cash and cash equivalents |
11,787 | 6,788 | ||||||
Financial assets |
— | 24,448 | ||||||
|
|
|
|
|||||
Total assets exposed to the risk |
11,787 |
31,236 |
||||||
|
|
|
|
Conversion rate |
Profit/(loss) |
Carrying amount |
||||||||||
(Euros in thousands) |
||||||||||||
Euro weakens by 1% against U.S. dollars |
1.1439 | (103 | ) | 10,307 | ||||||||
Euro strengths by 1% against U.S. dollars |
1.1213 | 105 | 10,516 | |||||||||
Euro weakens by 5% against U.S. dollars |
1.1892 | (496 | ) | 9,915 | ||||||||
Euro strengths by 5% against U.S. dollars |
1.0760 | 548 | 10,958 | |||||||||
Euro weakens by 10% against U.S. dollars |
1.2459 | (946 | ) | 9,464 | ||||||||
Euro strengths by 10% against U.S. dollars |
1.0193 | 1,157 | 11,567 |
Conversion rate |
Profit/(loss) |
Carrying amount |
||||||||||
(Euros in thousands) |
||||||||||||
Euro weakens by 1% against U.S. dollars |
1.1439 | (117 | ) | 11,670 | ||||||||
Euro strengths by 1% against U.S. dollars |
1.1213 | 119 | 11,906 | |||||||||
Euro weakens by 5% against U.S. dollars |
1.1892 | (561 | ) | 11,225 | ||||||||
Euro strengths by 5% against U.S. dollars |
1.0760 | 620 | 12,407 | |||||||||
Euro weakens by 10% against U.S. dollars |
1.2459 | (1,072 | ) | 10,715 | ||||||||
Euro strengths by 10% against U.S. dollars |
1.0193 | 1,310 | 13,096 |
Conversion rate |
Profit/ (loss) |
Carrying amount |
||||||||||
(Euros in thousands) |
||||||||||||
Euro weakens by 1% against U.S. dollars |
1.2394 |
(421 |
) |
42,107 |
||||||||
Euro strengths by 1% against U.S. dollars |
1.2148 |
430 |
42,958 |
|||||||||
Euro weakens by 5% against U.S. dollars |
1.2885 |
(2,025 |
) |
40,503 |
||||||||
Euro strengths by 5% against U.S. dollars |
1.1657 |
2,238 |
44,766 |
|||||||||
Euro weakens by 10% against U.S. dollars |
1.3498 |
(3,866 |
) |
38,662 |
||||||||
Euro strengths by 10% against U.S. dollars |
1.1044 |
4,725 |
47,253 |
Conversion rate |
Profit/ (loss) |
Carrying amount |
||||||||||
(Euros in thousands) |
||||||||||||
Euro weakens by 1% against U.S. dollars |
1.2394 |
(309 |
) |
30,927 |
||||||||
Euro strengths by 1% against U.S. dollars |
1.2148 |
316 |
31,552 |
|||||||||
Euro weakens by 5% against U.S. dollars |
1.2885 |
(1,487 |
) |
29,749 |
||||||||
Euro strengths by 5% against U.S. dollars |
1.1657 |
1,644 |
32,880 |
|||||||||
Euro weakens by 10% against U.S. dollars |
1.3498 |
(2,840 |
) |
28,396 |
||||||||
Euro strengths by 10% against U.S. dollars |
1.1044 |
3,471 |
34,707 |
As of |
||||||||
December 31, 2021 |
December 31, 2020 |
|||||||
(Euros in thousands) |
||||||||
Cash and cash equivalents |
132,994 | 207,530 | ||||||
Bonds |
12,123 | — | ||||||
Short-term deposits |
— | 24,448 | ||||||
|
|
|
|
|||||
Total funds available |
145,117 |
231,978 |
||||||
|
|
|
|
24. |
Financial Instruments |
Euros in thousands |
Carrying amount |
Fair value |
||||||||||||||||
IFRS 9 |
December 31, 2021 |
December 31, 2020 |
December 31, 2021 |
December 31, 2020 |
||||||||||||||
Financial assets |
||||||||||||||||||
Short-term deposits* |
other financial assets at amortized cost |
— | 24,448 | — | 24,448 | |||||||||||||
Bonds |
other financial assets at amortized cost |
12,123 | — | 12,113 | — | |||||||||||||
Positive market value |
At fair value through profit or loss (FVTPL) |
— | 914 | — | 914 | |||||||||||||
Accounts receivable |
other financial assets at amortized cost |
682 | 1,250 | 682 | 1,250 | |||||||||||||
Other current/non-current assets |
other financial assets at amortized cost |
691 | 1,586 | 691 | 1,586 | |||||||||||||
Total financial assets** |
13,496 |
28,198 |
13,486 |
28,198 |
||||||||||||||
Euros in thousands |
Carrying amount |
Fair value |
||||||||||||||||
IFRS 9 |
December 31, 2021 |
December 31, 2020 |
December 31, 2021 |
December 31, 2020 |
||||||||||||||
Financial liabilities |
||||||||||||||||||
Accounts payable |
other financial liabilities at amortized cost |
11,624 | 10,052 | 11,624 | 10,052 | |||||||||||||
Other current liabilities |
other financial liabilities at amortized cost |
727 | 962 | 727 | 962 | |||||||||||||
Other financial liabilities |
At fair value through profit or loss (FVTPL) |
27,859 | 16,869 | 27,859 | 16,869 | |||||||||||||
Total financial liabilities |
40,210 |
27,883 |
40,210 |
27,883 |
||||||||||||||
* | “Short-term deposits” are classified within Other financial assets. “Bonds” are classified within Other financial assets. “Positive market value forward contract” are classified in Other current assets. “Negative market value forward contracts” are classified in Other current liabilities. |
** | Financial assets, other than cash and cash equivalents. |
25. |
Commitments and contingencies |
Payments due by period |
||||||||||||||||||||
(Euros in thousands) |
Less than 1 year |
1 - 3 years |
3 - 5 years |
More than 5 years |
Total |
|||||||||||||||
Lease liabilities |
2,913 | 4,477 | 2,007 | 932 | 10,329 | |||||||||||||||
Other lease obligations |
66 | 1,258 | 1,362 | 2,040 | 4,726 | |||||||||||||||
Contract research organization agreements |
1,681 | — | — | — | 1,681 | |||||||||||||||
Total contractual cash obligation |
4,659 |
5,735 |
3,370 |
2,972 |
16,735 |
Payments due by period |
||||||||||||||||||||
(Euros in thousands) |
Less than 1 year |
1 - 3 years |
3 - 5 years |
More than 5 years |
Total |
|||||||||||||||
Lease liabilities |
2,103 | 3,453 | 1,157 | 150 | 6,863 | |||||||||||||||
Other lease obligations |
97 | 185 | 185 | 46 | 513 | |||||||||||||||
In-license agreements |
249 | — | — | — | 249 | |||||||||||||||
Contract research organization agreements |
1,704 | 220 | — | — | 1,924 | |||||||||||||||
Total contractual cash obligation |
4,153 |
3,858 |
1,342 |
196 |
9,549 |
26. |
Related party disclosures |
Year ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(Euros in thousands) |
||||||||||||
Fixed |
2,481 | 2,660 | 1,202 | |||||||||
Variable |
1,317 | 886 | 521 | |||||||||
Share-based compensation expense |
17,016 | 13,841 | 697 | |||||||||
Total key management compensation |
20,814 |
17,387 |
2,420 |
|||||||||
(Euros in thousands) |
Peter Chambré |
Friedrich von Bohlen |
Michael G. Atieh |
Paul Carter |
Heather L. Mason |
Adam Stone |
Christoph Hettich |
Eliot Forster |
Total |
|||||||||||||||||||||||||||
Board compensation |
80 | 20 | 55 | 53 | 40 | 40 | 20 | 40 | 348 | |||||||||||||||||||||||||||
Travel expenses |
— | 1 | 10 | — | 3 | — | — | 1 | 15 | |||||||||||||||||||||||||||
Share-based compensation expense |
1,143 | 30 | 114 | 114 | 114 | 114 | — | 122 | 1,751 | |||||||||||||||||||||||||||
Total cash compensation |
1,223 |
51 |
179 |
167 |
157 |
154 |
20 |
163 |
2,114 |
|||||||||||||||||||||||||||
(Euros in thousands) |
Peter Chambré |
Harald F. Stock |
Michael G. Atieh |
Paul Carter |
Heather L. Mason |
Adam Stone |
Christoph Hettich |
Eliot Forster |
Total |
|||||||||||||||||||||||||||
Supervisory board compensation |
140 | 16 | 28 | 26 | 20 | 20 | 20 | 12 | 282 | |||||||||||||||||||||||||||
Travel expenses |
4 | — | — | — | — | — | — | — | 4 | |||||||||||||||||||||||||||
Payment Exit arrangement |
2,394 | — | — | — | — | — | — | — | 2,394 | |||||||||||||||||||||||||||
Share-based compensation expense |
1,046 | — | 70 | 70 | 70 | 70 | 70 | 40 | 1,436 | |||||||||||||||||||||||||||
Total cash compensation |
3,584 |
16 |
98 |
96 |
90 |
90 |
90 |
52 |
4,116 |
|||||||||||||||||||||||||||
Peter Chambré |
Harald F. Stock |
Total |
||||||||||
(Euros in thousands) |
||||||||||||
Supervisory board fee |
300 | 9 | 309 | |||||||||
Travel expenses |
87 | 20 | 107 | |||||||||
Total |
387 |
29 |
416 |
|||||||||
Type of options |
Grant date |
Number of Options |
Strike Price in USD |
Expiration date |
||||||||||||||||
Managing Director |
||||||||||||||||||||
Harpreet Singh |
Performance- based options | June 30, 2020 | 1,598,000 | 10.00 | June 30, 2030 | |||||||||||||||
Harpreet Singh |
Service options | June 30, 2020 | 168,000 | 10.00 | June 30, 2030 | |||||||||||||||
Harpreet Singh |
Matching Stock options | June 30, 2020 | 264,624 | 10.00 | June 30, 2030 | |||||||||||||||
Harpreet Singh |
Converted options | June 30, 2020 | 30,939 | 1.06 | July 1, 2027 | |||||||||||||||
Harpreet Singh |
Converted options | June 30, 2020 | 145,371 | 1.17 | January 1, 2028 | |||||||||||||||
Harpreet Singh |
Service options | December 17, 2020 | 168,000 | 9.70 | December 17, 2030 | |||||||||||||||
Harpreet Singh |
Service options | December 9, 2021 | 168,000 | 11.00 | December 9, 2031 |
Type of options |
Grant date |
Number of Options |
Strike Price in USD |
Expiration date |
||||||||||||||||
Board of Directors |
||||||||||||||||||||
Peter Chambré |
Service options | June 30, 2020 | 25,000 |
10.00 |
June 30, 2030 |
|||||||||||||||
Peter Chambré |
Matching Stock options | June 30, 2020 | 211,974 |
10.00 |
June 30, 2030 |
|||||||||||||||
Peter Chambré |
Service options | December 9, 2021 | 15,000 |
11.00 |
December 9, 2031 |
|||||||||||||||
Adam Stone |
Service options | June 30, 2020 | 25,000 |
10.00 |
June 30, 2030 |
|||||||||||||||
Adam Stone |
Service options | December 9, 2021 | 15,000 |
11.00 |
December 9, 2031 |
|||||||||||||||
Heather L. Mason |
Service options | June 30, 2020 | 25,000 |
10.00 |
June 30, 2030 |
|||||||||||||||
Heather L. Mason |
Service options | December 9, 2021 | 15,000 |
11.00 |
December 9, 2031 |
|||||||||||||||
Michael G. Atieh |
Service options | June 30, 2020 | 25,000 |
10.00 |
June 30, 2030 |
|||||||||||||||
Michael G. Atieh |
Service options | December 9, 2021 | 15,000 |
11.00 |
December 9, 2031 |
|||||||||||||||
Paul Carter |
Service options | June 30, 2020 | 25,000 |
10.00 |
June 30, 2030 |
|||||||||||||||
Paul Carter |
Service options | December 9, 2021 | 15,000 |
11.00 |
December 9, 2031 |
|||||||||||||||
Eliot Forster |
Service options | September 14, 2020 | 25,000 |
9.16 |
September 13, 2030 |
|||||||||||||||
Eliot Forster |
Service options | December 9, 2021 | 15,000 |
11.00 |
December 9, 2031 |
|||||||||||||||
Friedrich von Bohlen |
Service options | June 17, 2021 | 25,000 |
12.05 |
June 17, 2031 |
|||||||||||||||
Friedrich von Bohlen |
Service options | December 9, 2021 | 15,000 |
11.00 |
December 9, 2031 |
27. |
Net loss per share |
28. |
Events occurring after the reporting period |
Immatics N.V. | ||||
By: |
/s/ Harpreet Singh | |||
Name: |
Harpreet Singh | |||
Title: |
Chief Executive Officer and Managing Director |
1 Year Immatics NV Chart |
1 Month Immatics NV Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions