☐ | 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 For the fiscal year ended December 31, 2018 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . |
☐ | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report_________________ |
Title of each class | Name of each exchange on which registered | |
Common Shares, nominal value €0.12 per share | The NASDAQ Stock Market LLC |
Large Accelerated Filer ☐ | Accelerated Filer ☒ | Non-accelerated Filer ☐ |
Emerging growth company ☒ |
☐ | U.S. GAAP |
☒ | International Financial Reporting Standards as issued by the International Accounting Standards Board |
☐ | Other |
This Amendment No. 1 on Form 20-F/A (the “Amendment”) amends the Annual Report on Form 20-F for the year ended December 31, 2018 of InflaRx N.V. (the “Company,” “we,” “our” or “us”), as originally filed with the U.S. Securities and Exchange Commission on March 28, 2019 (the “Original Annual Report”). We are filing this Amendment solely to (i) change the date of the Report of Independent Registered Accounting Firm (the “Accountants’ Report”) on page F-2 hereof to March 26, 2018 (from March 28, 2019); (ii) revise the penultimate sentence of Item 1 in Note 4(g) to our audited annual consolidated financial statements, appearing on page F-20, to read as follows: “The financial statements were authorized for issue by management on March 26, 2019.”; and (iii) in the Consolidated Statements of Cash Flows on page F-6, amend (x) the line item for “other non-cash adjustments” to read “421” instead of “(83)” and (y) the line item for “Interest received” to read “1,679” instead of “504.”
This Amendment does not reflect events occurring after the filing of the Original Annual Report and does not modify, update or restate the disclosure therein in any way other than to reflect the amendments described above. No other changes have been made in the Original Annual Report. The filing of this Amendment should not be understood to mean that any statements contained herein are true or complete as of any date subsequent to the date of filing of the Original Annual Report. The exhibits to this Amendment include updated certificates in Exhibits 12.1, 12.2, 13.1 and 13.2, in each case to reflect the date of this Amendment.
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F-1 |
· | the timing, progress and results of clinical trials of IFX-1 and any other product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; |
· | the timing of any submission of filings for regulatory approval of IFX-1 or any other product candidate, and the timing of and our ability to obtain and maintain regulatory approval of IFX-1 for any indication; |
· | our ability to leverage our proprietary anti-C5a technology to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; |
· | our ability to protect, maintain and enforce our intellectual property protection for IFX-1 and any other product candidates, and the scope of such protection; |
· | whether the FDA, EMA or comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; |
· | the success of our future clinical trials for IFX-1 and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials; |
· | our expectations regarding the size of the patient populations for, market opportunity for and clinical utility of IFX-1 or any other product candidates, if approved for commercial use; |
· | our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers for our planned future clinical trials; |
· | our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; |
· | our expectations regarding the scope of any approved indication for IFX-1; |
· | our ability to defend against costly and damaging liability claims resulting from the testing of our product candidates in the clinic or, if, approved, any commercial sales; |
· | our ability to commercialize IFX-1 or our other product candidates; |
· | if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; |
· | our ability to comply with enacted and future legislation in seeking marketing approval and commercialization; |
· | our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; |
· | our competitive position and the development of and projections relating to our competitors in the development of C5a inhibitors or our industry; and |
· | our expectations regarding the time during which we will be an emerging growth company under the JOBS Act or a foreign private issuer. |
For the year ended December 31, | ||||||||||||||||
2015 | 2016 | 2017 | 2018 | |||||||||||||
(in thousands of €, except for per share data) | ||||||||||||||||
Other income/(expenses)—net | 134 | 231 | 108 | 299 | ||||||||||||
Expenses: | ||||||||||||||||
Research and development expenses | (3,478 | ) | (5,278 | ) | (14,415 | ) | (25,028 | ) | ||||||||
General and administrative expenses | (438 | ) | (1,844 | ) | (5,138 | ) | (12,787 | ) | ||||||||
Loss before interest and income taxes | (3,782 | ) | (6,891 | ) | (19,445 | ) | (37,516 | ) | ||||||||
Net financial result | (1,135 | ) | (2,048 | ) | (4,793 | ) | 7,702 | |||||||||
Loss before income taxes | (4,917 | ) | (8,939 | ) | (24,238 | ) | (29,815 | ) | ||||||||
Income taxes | — | — | — | — | ||||||||||||
Loss for the period | (4,917 | ) | (8,939 | ) | (24,238 | ) | (29,815 | ) | ||||||||
Net loss per common share, basic and diluted(1) | (2.1 | ) | (3.8 | ) | (2.6 | ) | (1.2 | ) | ||||||||
Weighted average number of shares used to compute net loss per common share, basic and diluted | 2,363 | 2,363 | 9,411 | 25,095 |
(1) | There are no dilutive instruments outstanding |
As of December 31, | ||||||||||||||||
2015 | 2016 | 2017 | 2018 | |||||||||||||
(in thousands of €) | ||||||||||||||||
Cash and cash equivalents | 3,302 | 29,117 | 123,282 | 55,386 | ||||||||||||
Total assets | 3,586 | 29,518 | 124,213 | 159,214 | ||||||||||||
Total liabilities | 21,205 | 55,207 | 4,784 | 7,824 | ||||||||||||
Total equity | (17,619 | ) | (25,689 | ) | 119,429 | 151,391 |
Period end | Average for period | Low | High | |||||||||||||
(€ per $) | ||||||||||||||||
Year Ended December 31: | ||||||||||||||||
2014 | 0.8237 | 0.7570 | 0.7167 | 0.8237 | ||||||||||||
2015 | 0.9185 | 0.9053 | 0.8304 | 0.9477 | ||||||||||||
2016 | 0.9487 | 0.9065 | 0.8644 | 0.9649 | ||||||||||||
2017 | 0.8338 | 0.8795 | 0.8292 | 0.9629 | ||||||||||||
2018 | 0.8734 | 0.8784 | 0.8880 | 0.8005 | ||||||||||||
Quarter Ended | ||||||||||||||||
March 31, 2018 | 0.8116 | 0.8106 | 0.8381 | 0.8005 | ||||||||||||
June 30, 2018 | 0.8578 | 0.8563 | 0.8670 | 0.8072 | ||||||||||||
September 30, 2018 | 0.8639 | 0.8577 | 0.8833 | 0.8483 | ||||||||||||
December 31, 2018 | 0.8734 | 0.8784 | 0.8880 | 0.8616 | ||||||||||||
Month Ended: | ||||||||||||||||
September 30, 2018 | 0.8639 | 0.8577 | 0.8649 | 0.8491 | ||||||||||||
October 31, 2018 | 0.8835 | 0.8708 | 0.8836 | 0.8616 | ||||||||||||
November 30, 2018 | 0.8804 | 0.8797 | 0.8880 | 0.8706 | ||||||||||||
December 31, 2018 | 0.8734 | 0.8784 | 0.8861 | 0.8731 | ||||||||||||
January 31, 2019 | 0.8705 | 0.8760 | 0.8818 | 0.8669 | ||||||||||||
February 28, 2019 | 0.8759 | 0.8809 | 0.8880 | 0.8717 | ||||||||||||
March 2019 (through March 27, 2019) | 0.8880 | 0.8841 | 0.8911 | 0.8782 |
· | continue to develop and conduct clinical trials with respect to our lead product candidate, IFX-1, including in connection with the initiation of our ongoing Phase II and planned Phase III clinical trials of IFX-1 for HS, AAV and Pyoderma Gangraenosum, or PG as well as planned Phase II studies in the oncology field; |
· | initiate and continue research, preclinical and clinical development efforts for any future product candidates, including IFX-2; |
· | seek to identify additional product candidates; |
· | seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials, if any; |
· | establish sales, marketing, distribution and other commercial infrastructure in the future to commercialize various products for which we may obtain marketing approval, if any; |
· | require the manufacture of larger quantities of product candidates for clinical development and, potentially, commercialization; |
· | collaborate with strategic partners to optimize the manufacturing process for IFX-1 and IFX-2; |
· | maintain, expand and protect our intellectual property portfolio; |
· | hire and retain additional personnel, such as clinical, quality control and scientific personnel; and |
· | add operational, financial and management information systems and personnel, including personnel to support our product development and help us comply with our obligations as a public company. |
· | the scope, progress, timing, costs and results of clinical trials of, and research and preclinical development efforts for, our current and future product candidates, particularly for IFX-1; |
· | the number of future product candidates and indications that we pursue and their development requirements; |
· | the outcome, timing and costs of seeking regulatory approvals; |
· | the costs of commercialization activities for any of our product candidates that receive marketing approval to the extent such costs are not the responsibility of any future collaborators, including the costs and timing of establishing product sales, marketing, distribution and commercial-scale manufacturing capabilities; |
· | the effect of competing technological and market developments; |
· | subject to receipt of marketing approval, revenue, if any, received from commercial sales of our current and future product candidates; |
· | our ability to enter into, and the terms and timing of, any collaborations, licensing or other arrangements; |
· | our headcount growth and associated costs as we expand our research and development activities; |
· | the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights including enforcing and defending intellectual property related claims; and |
· | the costs of operating as a public company. |
· | incur additional unplanned costs, including costs relating to additional required clinical trials or preclinical testing; |
· | be delayed in obtaining marketing approval for IFX-1 or any of our other product candidates; |
· | not obtain marketing approval at all; |
· | obtain approval for indications or patient populations that are not as broad as intended or desired; |
· | obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings; |
· | be subject to additional post-marketing testing or other requirements; or |
· | be required to remove the product from the market after obtaining marketing approval. |
· | regulatory authorities may withdraw their approval of the product or seize the product; |
· | we, or any future collaborators, may need to recall the product, or be required to change the way the product is administered or conduct additional clinical trials; |
· | additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular product; |
· | we may be subject to fines, injunctions or the imposition of civil or criminal penalties; |
· | regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication; |
· | we, or any future collaborators, may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients; |
· | we, or any future collaborators, may be required to implement a REMS that imposes distribution and use restrictions or to conduct post-market studies or clinical trials; |
· | we, or any future collaborators, could be sued and held liable for harm caused to patients; |
· | the product may become less competitive; and |
· | our reputation may suffer. |
· | we may not be able to demonstrate that IFX-1 is safe and effective as a treatment for our targeted indications to the satisfaction of the FDA, the EMA or comparable foreign regulatory agencies; |
· | the FDA, EMA or comparable foreign regulatory authorities may require additional clinical trials or non-clinical studies of IFX-1 in addition to those already performed or planned, either before approval or as a post-approval commitment, which would increase our costs and prolong our development of IFX-1; |
· | the results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA, EMA or comparable foreign regulatory authorities for marketing approval; |
· | the FDA, EMA or comparable foreign regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical trials, including designated clinical endpoints, such as the use of HiSCR in our planned clinical trials of IFX-1 for HS; |
· | the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; |
· | the contract research organizations, or CROs, that we retain to conduct clinical trials may take actions outside of our control that materially adversely impact our clinical trials; |
· | the FDA, EMA or comparable foreign regulatory authorities may not find the data from preclinical studies and clinical trials sufficient to demonstrate that the clinical and other benefits of IFX-1 outweigh its safety risks; |
· | the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies and clinical trials; |
· | the FDA, EMA or comparable foreign regulatory authorities may not accept data generated at clinical trial sites; |
· | if our BLA, when submitted, is reviewed by an advisory committee, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; |
· | the FDA, EMA or comparable foreign regulatory authorities may require development of a risk evaluation and mitigation strategy, or REMS, as a condition of approval; |
· | the FDA, EMA or comparable foreign regulatory authorities may identify deficiencies in the manufacturing processes or facilities of our third-party manufacturers, including non-compliance with current Good Manufacturing Practices, or cGMPs; or |
· | the FDA, EMA or comparable foreign regulatory authorities may change their respective approval policies or adopt new regulations. |
· | severity of the disease under investigation; |
· | design of the clinical trial protocol; |
· | size and nature of the patient population; |
· | eligibility criteria for the trial in question; |
· | perceived risks and benefits of the product candidate under trial; |
· | perceived safety and tolerability of the product candidate; |
· | proximity and availability of clinical trial sites for prospective patients; |
· | availability of competing therapies and clinical trials; |
· | clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including standard-of-care and any new drugs that may be approved for the indications we are investigating; |
· | efforts to facilitate timely enrollment in clinical trials; |
· | patient referral practices of physicians; and |
· | our ability to monitor patients adequately during and after treatment. |
· | the efficacy and safety of the product; |
· | the potential advantages of the product compared to competitive therapies, notwithstanding success in meeting or exceeding clinical trial endpoints; |
· | the prevalence and severity of any side effects; |
· | whether the product is designated under physician treatment guidelines as a first-, second- or third-line therapy; |
· | our ability, or the ability of any future collaborators, to offer the product for sale at competitive prices; |
· | the product’s convenience and ease of administration compared to alternative treatments; |
· | the willingness of the target patient population to try, and of physicians to prescribe, the product; |
· | limitations or warnings, including distribution or use restrictions contained in the product’s approved labeling; |
· | the strength of sales, marketing and distribution support; |
· | changes in the standard of care for the targeted indications for the product; and |
· | availability and amount of coverage and reimbursement from government payors, managed care plans and other third-party payors. |
· | regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
· | clinical trials of our product candidates may produce negative or inconclusive results, including failure to demonstrate statistical significance, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs; |
· | our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials; |
· | our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; and |
· | regulators or institutional review boards may require that we or our investigators suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks. |
· | differing regulatory requirements in foreign countries; |
· | the potential for so-called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market (with low or lower prices) rather than buying them locally; |
· | unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements; |
· | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
· | foreign reimbursement, pricing and insurance regimes; |
· | 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; |
· | potential liability under the Foreign Corrupt Practices Act of 1977 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; |
· | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and |
· | business interruptions resulting from geo-political actions, including war and terrorism. |
· | the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs, such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. Further, several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the Anti-Kickback Statute has been violated. Moreover, the government may assert that 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 False Claims Act; |
· | federal civil and criminal false claims laws, including, without limitation, the federal civil False Claims Act (that can be enforced through civil whistleblower or qui tam actions), and the civil monetary penalties law, which impose criminal and civil penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; |
· | the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; |
· | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; |
· | the Physician Payments Sunshine Act, created under Section 6002 of Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the Affordable Care Act, and its implementing regulations, which requires specified manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other ‘‘transfers of value’’ made to physicians, which is defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals and applicable manufacturers to report annually to CMS ownership and investment interests held by physicians and their immediate family members by the 90th day of each calendar year. All such reported information is publicly available; and |
· | analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
· | an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs; |
· | an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively; |
· | expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, which include, among other things, new government investigative powers and enhanced penalties for non-compliance; |
· | a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; |
· | extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |
· | expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals, thereby potentially increasing manufacturers’ Medicaid rebate liability; |
· | extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |
· | expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals, thereby potentially increasing manufacturers’ Medicaid rebate liability; |
· | expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; |
· | the new requirements under the federal open payments program and its implementing regulations; |
· | a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and |
· | a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. |
· | restrictions on the manufacturing of such products; |
· | restrictions on the labeling or marketing of such products; |
· | restrictions on product distribution or use; |
· | requirements to conduct post-marketing studies or clinical trials; |
· | warning letters or untitled letters; |
· | withdrawal of the products from the market; |
· | refusal to approve pending applications or supplements to approved applications that we submit; |
· | recall of products; |
· | restrictions on coverage by third-party payors; |
· | fines, restitution or disgorgement of profits or revenues; |
· | suspension or withdrawal of marketing approvals; |
· | refusal to permit the import or export of products; |
· | product seizure; or |
· | injunctions or the imposition of civil or criminal penalties. |
· | reliance on third-parties for manufacturing process development, regulatory compliance and quality assurance; |
· | costs and validation of new equipment and facilities required for additional scale-up or optimization of processes; |
· | failure to comply with cGMP and similar foreign standards; |
· | limitations on supply availability resulting from capacity and scheduling constraints of third-parties; |
· | lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier; |
· | the possible breach of manufacturing agreements by third-parties because of factors beyond our control; and |
· | the possible termination or non-renewal of the manufacturing agreements by the third-party, at a time that is costly or inconvenient to us, and our ability to obtain alternative supply. |
· | a loss of key personnel within the manufacturing activities could result in significant delays in the manufacturing and release testing of our drug candidate and replacement of such personnel could be time consuming and be associated with additional costs for us; |
· | mistakes or misconduct within the release testing could result in false results which could result in both, the wrongfully rejection of a manufactured drug product from being released or the wrongfully acceptance of a dysfunctional drug product, causing data and trial results achieved with such drug product being false and potentially wrongly interpreted; and |
· | an inadequate GMP compliance could result in a potential temporary or permanent loss of the manufacturing or importing license resulting from an inspection of regulatory agencies. |
· | collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; |
· | collaborators may not perform their obligations as expected; |
· | collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs, based on clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing priorities; |
· | collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; |
· | collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates; |
· | a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products; |
· | disagreements with collaborators, including disagreements over proprietary rights, including trade secrets and intellectual property rights, contract interpretation, or the preferred course of development might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; |
· | collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; |
· | collaborators may infringe, misappropriate or otherwise violate the intellectual property rights of third parties, which may expose us to litigation and potential liability; |
· | collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and |
· | collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. If any future collaborator of ours is involved in a business combination, it could decide to delay, diminish or terminate the development or commercialization of any product candidate licensed to it by us. |
· | the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been the case; |
· | the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance; |
· | patent applications may not result in any patents being issued; |
· | patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked, circumvented, narrowed, found to be unenforceable or otherwise may not provide any competitive advantage; |
· | our competitors, many of whom have substantially greater resources and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use, and sell our potential product candidates; |
· | there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and |
· | countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates. |
· | we may not be able to generate sufficient data to support patent applications that protect the entire breadth of developments in one or more of our programs, including our HS program; |
· | it is possible that one or more of our pending patent applications will not become an issued patent or, if issued, that the patent(s) will be insufficient to protect our technology or products, provide us with a basis for commercially viable products or provide us with any competitive advantages; |
· | if our pending patent applications issue as patents, they may be challenged by third parties as not infringed, invalid or unenforceable under United States or foreign laws; or |
· | if issued, the patents under which we hold rights may not be valid or enforceable. |
· | the scope of rights that may be granted under license agreements and other interpretation-related issues; |
· | the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
· | the sublicensing of patent and other rights under current and any future collaborative development relationships; |
· | our diligence obligations under any license agreement and what activities satisfy such obligations; |
· | the inventorship and ownership of inventions and know-how and other intellectual property resulting from the joint creation or use of intellectual property by our license counterparties and us and our partners; and |
· | the priority of invention of patented technology. |
· | the timing, enrollment and results of clinical trials of IFX-1 and any other product candidates; |
· | regulatory actions with respect to IFX-1, our other product candidates or our competitors’ products and product candidates; |
· | the success of existing or new competitive products or technologies; |
· | any delay in our development or regulatory filings for IFX-1 or any future product candidate and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information; |
· | announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; |
· | commencement or termination of collaborations for our development programs; |
· | failure or discontinuation of any of our development programs; |
· | results of clinical trials of product candidates of our competitors; |
· | regulatory or legal developments in the United States and other countries; |
· | developments or disputes concerning patent applications, issued patents or other proprietary rights; |
· | the recruitment or departure of key personnel; |
· | the level of expenses related to any of our product candidates or clinical development programs; |
· | the results of our efforts to develop additional product candidates or products; |
· | actual or anticipated changes in estimates as to financial results or development timelines; |
· | announcement or expectation of additional financing efforts; |
· | sales of our common shares by us, our insiders or other shareholders; |
· | variations in our financial results or those of companies that are perceived to be similar to us; |
· | changes in estimates or recommendations by securities analysts, if any, that cover our shares; |
· | changes in the structure of healthcare payment systems; |
· | market conditions in the pharmaceutical and biotechnology sectors; |
· | general economic, industry and market conditions; and |
· | the other factors described in this “ITEM 3. KEY INFORMATION: — D. Risk factors” section. |
· | being permitted to provide only three years of audited financial statements with correspondingly reduced “ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS” disclosure in this Annual Report; |
· | not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting; |
· | reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and |
· | not being required to hold a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. |
· | Advance our lead program IFX-1 for HS to commercialization and advance subcutaneous IFX-1 treatment for HS. After a successful Phase IIa study, we have started a larger Phase IIb study in 179 patients to determine the most effective dose regimen for IFX-1 intravenoustreatment of HS. Following the read-out of the Phase IIb trial, we plan to design and discuss with the FDA and EMA a Phase III program that will support a regulatory application for IFX- treatment for HS. In addition, we plan to develop subcutaneous IFX-1 treatment for HS patients in order to offer more convenient administration of IFX-1 for HS patients in the future. |
· | Commence Phase II clinical development of IFX-1 for AAV , PG, oncological diseases and other complement-mediated autoimmune and inflammatory diseases. We are developing IFX-1 for the treatment of AAV, and we have initiated a Phase II program consisting of two clinical trials. We plan to seek orphan drug designation for AAV in the United States and Europe. For PG, we plan to conduct an open-label proof-of-concept Phase IIa study in Canada that has recently been approved by Canada Health. In addition, we plan to to study the potential benefit of IFX-1 treatment in oncological diseases and other complement-mediated autoimmune and inflammatory diseases in the future. |
· | Pursue the clinical development of IFX-2 and continue to expand the breadth of our anti-C5a technology. We are developing IFX-2 as an injectable with a longer half-life than IFX-1, making it suitable for chronic inflammatory indications with less severe flares or closer to the onset of disease. IFX-2 shares the same features as IFX-1 with respect to its mechanism of action, covered binding epitope and selectivity. The pre-clinical development of IFX-2 is supported by a grant from the German government. We believe IFX-2 holds the potential to treat various chronic inflammatory diseases that could benefit from a dosing regimen more suitable for chronic therapy. |
· | Commercialize IFX-1, if approved, either independently or in collaboration with a partner. We intend to independently pursue the approval and commercialization of IFX-1 for HS in the United States and Europe. We plan to employ a small, targeted commercial infrastructure to promote access to IFX-1 through centers-of-excellence that treat HS in these core markets. Outside of the United States and Europe, we may pursue the approval and commercialization of IFX-1 for HS either independently or in collaboration with others. For other indications, we intend to develop and commercialize IFX-1 either independently or through collaborations with other parties. |
· | Solidify our leadership position in the anti-C5a space by leveraging the full potential of our proprietary anti-C5a technology and expertise in complement and inflammation. We intend to continue to discover and develop treatments that have the potential to address a broad spectrum of complement-mediated or immune response mediated indications with significant unmet need, either internally or in collaboration with a partner. To accomplish this, we have supplemented our research and development activities with an additional discovery unit in Ann Arbor, Michigan and we are further building out our business development capabilities. |
· | Rapid creation of an inflammatory environment. Production of pro-inflammatory molecules, such as C5a, optimizes the conditions under which enzymatic and other processes can act against microorganisms. These inflammatory conditions include the onset of a fever or release of aggressive enzymes and oxygen radicals by neutrophils. |
· | Lysis of microorganisms through formation of the Membrane Attack Complex. A rapid, first-line defense mechanism resulting in the formation of pores in the cell membranes of invading microorganisms, leading to their disintegration. |
· | Bridge to the adaptive immune system. This function is promoted by an activation product of C3, called C3b, which tags particles and makes them visible and more easily processed by immune stimulatory cells. Such cells then present these particles to B-cells, which in turn generate antibodies against the particles, leading to targeted elimination. This mechanism takes a few weeks to take full effect. |
· | Clearance of dead cell particles. The complement system also serves various other purposes, including the clearance of dead cell particles from the body. This function is especially important because uncleared cell particles are believed to potentially induce generation of antibodies against normal cells and tissues, leading to autoimmune inflammatory responses and diseases. |
· | C5a boosts the generation of many different cytokines such as IL-8, IL-6, IL17, TNF-alpha and others in a variety of cell types as well as within the bloodstream. |
· | C5a induces a complex change in the cell-signaling cascade of immune-competent cells that leads to an altered and often intensified signal transduction of other known signaling stimuli, such as the Toll-like receptor signaling. |
· | C5a affects T-cell responses and causes a pro-inflammatory response, leading to the generation of further pro-inflammatory cytokines. |
· | C5a is capable of inducing adhesion molecule expression on the surfaces of blood vessels, leading to neutrophil adherence to the internal vessel wall and migration through the vessel to the site of infection. |
· | Complete immunological blockade and inhibition of C5a-induced effects: The human body has an abundant capacity to generate C5a, and induce inflammatory effects through its two receptors, C5aR and C5L2. Therefore our anti-C5a antibodies are designed to: |
· | generate complete immunological blockade of the C5a molecule to achieve potent and effective treatments. Antibodies or inhibitors lacking this quality may leave a “signaling gap” for C5a, which, in a disease setting, will likely be sufficient to allow for strong pro-inflammatory effects. This signaling gap would limit the ability to silence the C5a/C5aR and C5a/C5L2 signaling axis to achieve the desired therapeutic effect; and |
· | bind with high affinity to C5a to counteract the molecule’s rapid interactions with its two receptors, C5aR and C5L2, which are abundantly present on the vast majority of cell types in the human body and that can be up-regulated in various disease settings. |
· | Limited effect on MAC formation: C5 blocking molecules that inhibit MAC formation in the blood increase the risk of life-threatening infections caused by encapsulated bacteria such as meningococci. Therefore, leaving MAC formation intact may offer a significant advantage in C5a driven diseases. |
· | Inability to fully block C5a without targeting it directly: C5a can be generated through C5 activation by various enzymes in the complete absence of the complement pathways. For example, blocking the complement C5-convertase-driven cleavage with the C5 inhibitor eculizumab cannot block direct enzymatic C5 activation and C5a generation in an experimental setting. This may explain why elevated C5a levels remain measurable in patients effectively dosed with eculizumab. Therefore, non-specific approaches that do not bind and inhibit C5a directly may fail to fully block its effects; and |
· | Lack of control over C5a’s signaling ability: C5a receptors are abundantly present on the majority of cells in humans and can be strongly and rapidly upregulated in certain disease states. As such, even with low levels of C5a, the receptors create a large “signaling sink” providing an abundant ability for even small amounts of C5a to transmit a signal. Therefore, a fully blocking targeted C5a approach is warranted in order to achieve full control over C5a-induced signaling events which may be especially important in highly acute inflammatory settings. |
· | fully inhibit C5a-induced signaling and derived biological functions, as evidenced by its ability to completely prevent C5a-induced neutrophil activation in human whole blood; and |
· | leave MAC formation intact, as evidenced by testing the intact complement pathway driven MAC formation on red blood cells, leading to the lysis of these cells. |
· | good rationale for the role of C5a and initial clinical data suggesting a strong benefit for the use of IFX-1; |
· | large market opportunity with potential for orphan drug designation in the United States; |
· | high unmet medical need; |
· | path to approval based upon HiSCR response supported by prior FDA approval of adalimumab for the treatment of HS; and |
· | potential for fast recruitment based on historical enrollment results for the adalimumab pivotal trials. |
· | Rapid onset of action: IFX-1 has fast onset of action such that after its intravenous administration, IFX-1 inhibits C5a-induced signaling completely, providing immediate protection from C5a induced priming and activation of neutrophils in this disease. This may result in a faster response rate and a potentially quicker induction of remission when compared to the currently available treatment options. |
· | Potential safety benefits: IFX-1 is a monoclonal antibody that was well tolerated in one Phase I and three Phase IIa clinical studies, with a total of over 170 treated patients or healthy human volunteers. We believe that the properties of IFX-1, which blocks C5a and not its receptors, may allow IFX-1 to avoid safety concerns arising from potential receptor-related signaling effects or other off-target effects which may be related through binding on the surface of highly active immune competent cells, such as T-cells or dendritic cells. |
· | An open-label single center trial in the US enrolling 18 out of originally planned 21 patients with moderate to severe HS has recently been concluded with Secukinumab, a monoclonal antibody blocking interleukin-17A and initial conference reports suggested improvement of the HiSCR at last observation carried forward. |
· | Another open-label trial with Secukinumab enrolling 17 HS patients at a center in France has recently been conducted and reported first results during the European HS foundation meeting in February 2019, suggesting that 13 patients showed a HiSCR response at 4 months of treatment. In this study, two patients developed Crohn´s disease on months four of treatment which remained active after immediate treatment stop throughout the 14 months trial period. Induction of Crohn´s disease is a known side effect of secukinumab and Crohn´s disease has been reported to be associated with HS disease. |
· | An open-label trial for Janssen-Cilag’s ustekinumab was recently completed in 12 HS patients. Ustekinumab is a monoclonal antibody directed against IL12 and IL23. |
· | A small placebo-controlled Phase II study for Swedish Orphan Biovitrum AB’s anakinra, as well as an open-label single-center trial in six patients, were completed in HS patients suggesting potential efficacy in a modified intent-to-treat population. Anakinra is an IL-1 receptor antagonist. |
· | preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the applicable EU Good Laboratory Practice regulations; |
· | submission to the relevant national authorities of a clinical trial application or CTA for each trial in humans, which must be approved before the trial may begin in each country where patient enrollment is planned; |
· | performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed indication; |
· | submission to the relevant competent authorities of a Marketing Authorization Application or MAA, which includes the data supporting safety and efficacy as well as detailed information on the manufacture and composition of the product in clinical development and proposed labelling; |
· | satisfactory completion of an inspection by the relevant national authorities of the manufacturing facility or facilities, including those of third parties, at which the product is produced to assess compliance with strictly enforced current Good Manufacturing Practices; |
· | potential audits of the non-clinical and clinical trial sites that generated the data in support of the MAA; and |
· | review and approval by the relevant competent authority of the MAA before any commercial marketing, sale or shipment of the product. |
(a)(i) | that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the European Union when the application is made, or; |
(a)(ii) | that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the European Union and that without incentives it is unlikely that the marketing of the drug in the European Union would generate sufficient return to justify the necessary investment; and |
(b) | that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized in the European Union or, if such method exists, the drug will be of significant benefit to those affected by that condition. |
· | progress to Phase III clinical trial of IFX-1 in HS; |
· | continue to advance our lead product candidate, IFX-1, through additional clinical development, including by conducting a Phase II clinical trial program of IFX-1 in AAV and PG; |
· | initiate and continue our current research programs and development activities, including development of IFX-2; |
· | seek to identify additional research programs and additional product candidates; |
· | maintain, expand and protect our intellectual property portfolio; |
· | hire and retain additional personnel, such as clinical quality control and scientific personnel; and |
· | incur additional costs associated with operating as a public company, including expanding our operational, finance and management teams. |
· | expenses incurred under agreements with contract research organizations, or CROs, contract manufacturing organizations, or CMOs, consultants and independent contractors that conduct research and development, preclinical and clinical activities on our behalf; |
· | employee-related expenses, including salaries, benefits and stock-based compensation expense based upon employees’ role within the organization; and |
· | professional fees for lawyers related to the protection and maintenance of our intellectual property. |
· | IFX-1. In 2017, we completed enrollment and dosing in our Phase IIa clinical trial of IFX-1 in patients with HS. In the fourth quarter of 2018, we completed enrollment of our Phase IIb clinical trial of IFX-1 in patients with HS. We expect our expenses associated with IFX-1 will further increase as we prepare to commence a Phase III clinical trial of IFX-1 in patients with HS, conduct our Phase II clinical program of IFX-1 in patients with AAV and prepare to commence a Phase II clinical trial program in patients with PG. We anticipate that our research and development expenses will increase substantially in connection with the commencement of these and any additional clinical trials. In addition, we are also incurring expenses related to the manufacturing of clinical trial material and investigating commercial scale production options. |
· | IFX-2. We are continuing preclinical development of IFX-2, expenses for which mainly consist of salaries, costs for preclinical testing conducted by CROs and costs for the production of preclinical material. |
· | Other development programs. Our other research and development expenses relate to our preclinical studies of other product candidates and discovery activities, expenses for which mainly consist of salaries, costs for production of preclinical compounds and costs paid to CROs. |
· | clinical trials or our product candidates producing negative or inconclusive results, including failure to demonstrate statistical significance; |
· | the scope, rate of progress, results and cost of our clinical trials, nonclinical testing, and other related activities; |
· | delays in reaching, or failing to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites or prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
· | the cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any products that we may develop; |
· | third-party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
· | the number and characteristics of product candidates that we pursue; |
· | undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or institutional review boards to suspend or terminate the trials; |
· | potential additional safety monitoring or other studies requested by regulatory agencies; |
· | the cost, timing, and outcomes of regulatory approvals; |
· | the number of trials required for approval; |
· | the duration of patient follow-up; |
· | the cost and timing of establishing sales, marketing, and distribution capabilities; and |
· | the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any milestone and royalty payments thereunder. |
· | employee-related expenses, including salaries, benefits and stock-based compensation expense based upon employees’ role within the organization; |
· | professional fees for auditors and consulting expenses not related to research and development activities; |
· | professional fees for lawyers not related to the protection and maintenance of our intellectual property; and |
· | cost of facilities, communication and office expenses. |
Year ended December 31, | ||||||||||||
2017 | 2018 | Change | ||||||||||
(in thousands of €) | ||||||||||||
Other income and expenses (net) | 108 | 299 | 191 | |||||||||
Research and development expenses | (14,415 | ) | (25,028 | ) | (10,613 | ) | ||||||
General and administrative expenses | (5,138 | ) | (12,787 | ) | (7,649 | ) | ||||||
Loss before interest and income taxes | (19,445 | ) | (37,516 | ) | (18,071 | ) | ||||||
Net financial result | (4,793 | ) | 7,702 | 12,495 | ||||||||
Loss before tax | (24,238 | ) | (29,815 | ) | (5,577 | ) | ||||||
Income tax expense | — | — | — | |||||||||
Loss for the period | (24,238 | ) | (29,815 | ) | (5,577 | ) | ||||||
Exchange differences on translating foreign operations | 0 | 51 | 51 | |||||||||
Total comprehensive loss | (24,238 | ) | (29,764 | ) | (5,526 | ) |
Year ended December 31, | ||||||||||||
2017 | 2018 | Change | ||||||||||
(in thousands of €) | ||||||||||||
Third party expenses | 8,856 | 15,909 | 7,053 | |||||||||
Personnel expenses | 4,681 | 8,037 | 3,356 | |||||||||
Other expenses | 878 | 1,082 | 204 | |||||||||
Total | 14,415 | 25,028 | 10,613 |
Year ended December 31, | ||||||||||||
2017 | 2018 | Change | ||||||||||
(in thousands of €) | ||||||||||||
General and administrative expense: | ||||||||||||
Personnel expenses | 2,948 | 9,147 | 6,199 | |||||||||
Legal, consulting and audit fees | 1,478 | 2,020 | 542 | |||||||||
Other expenses | 712 | 1,619 | 907 | |||||||||
Total | 5,138 | 12,787 | 7,649 |
Year ended December 31, | ||||||||||||
2017 | 2018 | Change | ||||||||||
(in thousands of €) | ||||||||||||
Foreign exchange gain | 0 | 8,250 | 8,250 | |||||||||
Interest and other income | 130 | 2,183 | 2,053 | |||||||||
Total finance costs | 130 | 10,433 | 10,303 | |||||||||
Foreign exchange loss | (2,358 | ) | (2,624 | ) | (266 | ) | ||||||
Other finance costs | (2,564 | ) | (107 | ) | 2,457 | |||||||
Total finance costs | (4,923 | ) | (2,731 | ) | 2,192 | |||||||
Net financial result | (4,793 | ) | 7,702 | 12,495 |
Year ended December 31, | ||||||||||||
2016 | 2017 | Change | ||||||||||
(in thousands of €) | ||||||||||||
Other income and expenses (net) | 231 | 108 | (123 | ) | ||||||||
Research and development expenses | (5,278 | ) | (14,415 | ) | (9,137 | ) | ||||||
General and administrative expenses | (1,844 | ) | (5,138 | ) | (3,294 | ) | ||||||
Loss before interest and income taxes | (6,891 | ) | (19,445 | ) | (12,554 | ) | ||||||
Net financial result | (2,048 | ) | (4,793 | ) | (2,745 | ) | ||||||
Loss before tax | (8,939 | ) | (24,238 | ) | (15,299 | ) | ||||||
Income tax expense | — | — | — | |||||||||
Loss for the period | (8,939 | ) | (24,238 | ) | (15,299 | ) | ||||||
Exchange differences on translating foreign operations | 1 | - | (1 | ) | ||||||||
Total comprehensive loss | (8,938 | ) | (24,238 | ) | (15,300 | ) |
Year ended December 31, | ||||||||||||
2016 | 2017 | Change | ||||||||||
(in thousands of €) | ||||||||||||
Third party expenses | 3,757 | 8,856 | 5,099 | |||||||||
Personnel expenses | 1,293 | 4,681 | 3,388 | |||||||||
Other | 228 | 878 | 650 | |||||||||
Total | 5,278 | 14,415 | 9,137 |
Year ended December 31, | ||||||||||||
2016 | 2017 | Change | ||||||||||
(in thousands of €) | ||||||||||||
General and administrative expense: | ||||||||||||
Personnel expenses | 1,134 | 2,948 | 1,814 | |||||||||
Legal, consulting and audit fees | 394 | 1,478 | 1,088 | |||||||||
Other | 316 | 712 | 392 | |||||||||
Total | 1,844 | 5,138 | 3,294 |
Year ended December 31, | ||||||||
2017 | 2018 | |||||||
(in thousands of €) | ||||||||
Net cash used in operating activities | (12,152 | ) | (23,712 | ) | ||||
Net cash used in investing activities | (167 | ) | (99,451 | ) | ||||
Net cash from financing activities | 108,801 | 49,642 | ||||||
Cash and cash equivalents at the beginning of the period | 29,117 | 123,282 | ||||||
Exchange gains on cash and cash equivalents | (2,317 | ) | 5,626 | |||||
Cash and cash equivalents at the end of the period | 123,282 | 55,386 |
Year ended December 31, | ||||||||
2016 | 2017 | |||||||
(in thousands of €) | ||||||||
Net cash used in operating activities | (4,992 | ) | (12,152 | ) | ||||
Net cash used in investing activities | (53 | ) | (167 | ) | ||||
Net cash from financing activities | 30,860 | 108,801 | ||||||
Cash and cash equivalents at the beginning of the period | 3,302 | 29,117 | ||||||
Exchange gains on cash and cash equivalents | 1 | (2,317 | ) | |||||
Cash and cash equivalents at the end of the period | 29,117 | 123,282 |
Payments due by Period | ||||||||||||||||||||
Total | Less than 1 year | Between 1 and 3 Years | Between 3 and 5 Years | More than 5 years | ||||||||||||||||
(in thousands of €) | ||||||||||||||||||||
Contractual CRO commitments and other contractual obligations under non-cancellable operating contracts or services: | 29,307 | 19,624 | 9,648 | 36 | 0 | |||||||||||||||
Contractual lease obligations | 575 | 283 | 292 | 0 | 0 | |||||||||||||||
Total | 29,883 | 19,907 | 9,940 | 36 | 0 |
Name | Position | Age | Initial year of appointment at InflaRx GmbH or InflaRx N.V. (as applicable)*** | |||
Anthony Gibney | Non-Executive Director | 48 | 2018 | |||
Arnd Christ | Chief Financial Officer | 52 | 2015 | |||
Jason Marks | Chief Legal Officer | 43 | 2019 | |||
Jens Holstein* | Non-Executive Director | 55 | 2018 | |||
Katrin Uschmann | Non-Executive Director | 54 | 2007 | |||
Lina Ma | Non-Executive Director | 41 | 2016 | |||
Maria Habel | Head of Preclinical Research and Development | 36 | 2008 | |||
Mark Kubler | Non-Executive Director | 43 | 2015 | |||
Nicolas Fulpius | Non-Executive Director and Chairman of the Board | 45 | 2007 | |||
Niels Riedemann | Executive Director and Chief Executive Officer | 47 | 2007 | |||
Othmar Zenker | Chief Medical Officer | 56 | 2013 | |||
Renfeng Guo | Executive Director and Chief Scientific Officer | 49 | 2007 | |||
Richard Brudnick** | Non-Voting Observer | 63 | 2019 |
· | recommending the appointment of the independent auditor to the general meeting of shareholders; |
· | the appointment, compensation, retention and oversight of any accounting firm engaged for the purpose of preparing or issuing an audit report or performing other audit services; |
· | pre-approving the audit services and non-audit services to be provided by our independent auditor before the auditor is engaged to render such services; |
· | evaluating the independent auditor’s qualifications, performance and independence, and presenting its conclusions to the full supervisory board on at least an annual basis; |
· | reviewing and discussing with the board of directors and the independent auditor the audit plan as well as our annual audited financial statements and quarterly financial statements prior to the filing of the respective annual and quarterly reports; |
· | reviewing our compliance with laws and regulations, including major legal and regulatory initiatives and also reviewing any major litigation or investigations against us that may have a material impact on our financial statements; |
· | reviewing internal audit results, including the effectiveness of the design and operation of our internal controls; |
· | reviewing the operation of and our compliance with our code of ethics; and |
· | approving or ratifying any related person transaction (as defined in our related person transaction policy) in accordance with our related person transaction policy and reviewing potential conflicts of interest involving our directors. |
· | identifying, reviewing and approving corporate goals and objectives relevant to compensation of our executive officers and directors; |
· | analyzing the possible outcomes of the variable remuneration components and how they may affect the remuneration of our executive officers; |
· | determining any long-term incentive component of each executive officer’s compensation in line with the compensation policy and reviewing our executive officer compensation and benefits policies generally; |
· | preparing periodic compensation reports for our board of directors; |
· | reviewing and assessing risks arising from our employee compensation policies and practices and whether any such risks are reasonably likely to have a material adverse effect on us; and |
· | retaining or obtaining advice from a compensation consultant, legal counsel or other advisor as the compensation committee deems necessary or appropriate to carry out its responsibilities. |
· | preparing and reviewing selection criteria and appointment procedures for our board of directors; |
· | reviewing the size and composition of our board of directors and submitting proposals for the composition profile of our board of directors; |
· | leading the board of directors in self-evaluation to determine whether it and its committees are functioning effectively; |
· | preparing and reviewing a plan for succession of directors; and |
· | submitting proposals for the appointment or reappointment of directors. |
· | each person, or group of affiliated persons, known by us to own beneficially 5% or more of our outstanding common shares (as of the date of such shareholder’s Schedule 13G filing for InflaRx N.V. with the SEC); |
· | each of our directors and senior management; and |
· | all directors and senior management as a group. |
Common Shares Beneficially Owned | ||||||||
Number | Percent of | |||||||
5% Shareholders | ||||||||
Adage Capital Partners GP, L.L.C.(1) | 2,680,959 | 10.3 | % | |||||
Entities affiliated with Staidson Hong Kong Investment Company Limited (2) | 2,317,644 | 8.9 | % | |||||
Entities affiliated with RA Capital Management, LLC(3) | 2,085,089 | 8.0 | % | |||||
Redmile Group, LLC (4) | 2,035,400 | 7.8 | % | |||||
Bain Capital Life Sciences Investors, LLC (5) | 1,764,888 | 6.8 | % | |||||
Cormorant Asset Management, LP (6) | 1,475,140 | 5.7 | % | |||||
Entities affiliated with Private Equity Thüringen GmbH & Co (7) | 1,340,736 | 5.2 | % | |||||
Directors and Senior Management | ||||||||
Niels Riedemann(8) | 1,820,143 | 6.8 | % | |||||
Renfeng Guo(9) | 1,786,395 | 6.7 | % | |||||
Arnd Christ(10) | 278,586 | 1.1 | % | |||||
Othmar Zenker(11) | 134,497 | * | ||||||
Jason Marks (12) | 25,000 | * | ||||||
Mark Kubler(13) | 757,676 | 2.9 | % | |||||
Nicolas Fulpius(14) | 427,617 | 1.6 | % | |||||
Katrin Uschmann(15) | 29,480 | * | ||||||
Lina Ma(16) | 14,360 | * | ||||||
Anthony Gibney (17) | 11,667 | * | ||||||
Jens Holstein | * | * | ||||||
Richard Brudnick ** | * | * | ||||||
All directors and senior management as a group (12 persons) | 5,285,421 | 18.8 | % |
* | Indicates beneficial ownership of less than 1% of the total outstanding common shares. |
** | Since February 14, 2019, Mr. Brudnick served as a non-voting observer. The appointment as a Non-Executive Director of the Board is subject to the approval at the Annual General Meeting of Shareholders in May 2019. |
(1) | Adage Capital Partners GP, L.L.C. (“ACPGP”) is the general partner of Adage Capital Partners, L.P. (“ACP”). Adage Capital Advisors, L.L.C. (“ACA”) is the managing member of ACPGP and general partner of ACP. Robert Atchinson and Phillip Gross are each a managing member of ACA, managing member of ACPGP and general partner of ACP. Mr. Atchinson and Mr. Gross, as managing members of ACA, have shared power to vote the common shares beneficially owned by ACP. As a result, each may be deemed to beneficially own the shares beneficially owned by ACP. The address of the Adage Capital Partners, L.P. is 200 Clarendon Street, 52nd floor, Boston, Massachusetts 02116. This information is based on a statement filed on Schedule 13G/A with the SEC on November 20, 2018. |
(2) | Staidson Hong Kong Investment Company Limited (“STS”) is wholly owned by Staidson (Beijing) Biopharmaceuticals Co., Ltd., a publicly-held entity whose common shares are listed on the Shenzhen Stock Exchange. The address for STS is 1/F 122D Ma Yautong Sai Kung, Hong Kong. |
(3) | RA Capital Management, LLC (“Capital”) is the general partner of the RA Capital Healthcare Fund, L.P. (the “Fund”), which owns 1,700,332 common shares, and serves as investment adviser for a separately managed account (the “Account”), which owns 384,757 common shares. Dr. Kolchinsky is the manager of Capital. As the investment adviser to the Fund and the Account, Capital may be deemed a beneficial owner of any securities of the Company owned by the Fund or the Account. As the manager of Capital, Dr. Kolchinsky may be deemed a beneficial owner of any securities of the Company beneficially owned by Capital. Capital and Dr. Kolchinsky disclaim beneficial ownership of all applicable shares except to the extent of their actual pecuniary interest therein. The address of Capital and Dr. Kolchinsky is c/o RA Capital Management, LLC 20 Park Plaza, Suite 1200, Boston, Massachusetts 02116. This information is based on a statement filed on Schedule 13G/A with the SEC on February 14, 2019. |
(4) | Redmile Group, LLC (“Redmile Group”)’s and Jeremy C. Green’s beneficial ownership is comprised of 2,035,400 common shares owned by certain private investment vehicles and/or separately managed accounts managed by Redmile Group, which common shares may be deemed beneficially owned by Redmile Group as investment manager of such private investment vehicles and/or separately managed accounts. The common shares may also be deemed beneficially owned by Jeremy C. Green as the principal of Redmile Group. Redmile Group and Mr. Green each disclaim beneficial ownership of all applicable shares, except to the extent of its or his pecuniary interest in such shares, if any. The address of Redmile Group and Mr. Green is c/o Redmile Group, LLC One Letterman Drive, Building D, Suite D3-300, The Presidio of San Francisco, San Francisco, California 94129. This information is based on a statement filed on Schedule 13G with the SEC on February 14, 2019. |
(5) | The governance, investment strategy and decision-making process with respect to investments held by BCLS Investco, L.P. is directed by Bain Capital Life Sciences Investors, LLC, whose managers are Jeffrey Schwartz and Adam Koppel. As a result, each of Bain Capital Life Sciences Investors, LLC, Mr. Schwartz and Dr. Koppel may be deemed to share voting and dispositive power over the shares held by BCLS Investco, L.P. The address for BCLS Investco, L.P. is c/o Bain Capital Life Sciences, LP, 200 Clarendon Street, Boston, Massachusetts 02116. This information is based on a statement filed on Schedule 13G/A with the SEC on February 14, 2019. |
(6) | Cormorant Asset Management, LP (“Cormorant”) represent shares which are 774,465 common shares held by Cormorant Global Healthcare Master Fund, LP (the “Master Fund”), (b) shares which are beneficially owned by Cormorant Private Healthcare Fund I, LP (the “Fund”) and (c) a managed account (the “ Cormorant Account”), respectively. Cormorant Asset Management, LP serves as investment manager for the Master Fund, the Fund and the Cormorant Account. Cormorant Global Healthcare GP, LLC (“Healthcare GP”) serves as the general partner of the Master Fund. Bihua Chen serves as the managing member of Healthcare GP and of the general partner of Cormorant. Each of the Master Fund, Healthcare GP, Cormorant and Bihua Chen disclaims beneficial ownership of all applicable shares except to the extent of their actual pecuniary interest therein. The address of the Master Fund, Healthcare GP, Cormorant and Bihua Chen is c/o Cormorant Asset Management, LP 200 Clarendon Street, 52nd Floor Boston, MA 02116. This information is based on a statement filed on Schedule 13G/A with the SEC on February 14, 2019. |
(7) | Consists of (a) 592,296 common shares held by Private Equity Thüringen GmbH & Co. (“PET I”) and (b) 748,440 common shares held by Private Equity Thüringen Zweite Beteiligungen GmbH (“PET II”). Kevin Reeder is the managing director of PET I and PET II and may be deemed to have voting and investment power over the shares held by PET I and PET II noted above. The address for PET I and PET II is Gorkistr. 9, D-99084 Erfurt, Germany. This information is based on a statement filed on Schedule 13G/A with the SEC on February 8, 2019. |
(8) | Consists of (a) 997,500 common shares, (b) 404,040 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2016 Plan at an exercise price of €7.81 per share, which shall expire on November 18, 2031, (c) 126,005 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the Series B financing at an exercise price of €0.0012 per share, (d) 287,189 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$18.05 per share, which shall expire on December 13, 2025 and 5,409 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$26.02 per share, which shall expire on November 20, 2026. |
(9) | Consists of (a) 1,043,601 common shares, (b) 336,672 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2016 Plan at an exercise price of €7.81 per share, which shall expire on November 18, 2031, (c) 140,876 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the Series B preferred financing (the “Series B financing”) at an exercise price of €0.0012 per share, (d) 259,837 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$18.05 per share, which shall expire on December 13, 2025 and 5,409 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$26.02 per share, which shall expire on November 20, 2026. |
(10) | Consists of (a) 6,384 common shares, (b) 202,020 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2016 Plan at an exercise price of €7.81 per share, which shall expire on November 18, 2031, (c) 68,379 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$18.05 per share, which shall expire on December 13, 2025 and 1,803 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$26.02 per share, which shall expire on November 20, 2026. |
(11) | Consists of (a) 86,632 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2016 Plan at an exercise price of €7.81 per share, which shall expire on March 1, 2032, and (b) 47,865 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$18.05 per share, which shall expire on December 13, 2025. |
(12) | Consists of 25,000 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$26.02 per share, which shall expire on November 20, 2026. |
(13) | Consists of (a) 736,008 common shares, (b) 7,308 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the Series B financing at an exercise price of €0.0012 per share, and (c) 14,360 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$18.05 per share, which shall expire on December 13, 2025. |
(14) | Consists of (a) 413,257 common shares, and (b) 14,360 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$18.05 per share, which shall expire on December 13, 2025. |
(15) | Consists of (a) 15,120 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the Series B financing at an exercise price of €0.0012 per share, and (b) 14,360 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$18.05 per share, which shall expire on December 13, 2025. |
(16) | Consists of 14,360 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$18.05 per share, which shall expire on December 13, 2025. |
(17) | Consists of 11,667 common shares that may be acquired pursuant to the exercise of options which were issued pursuant to the 2017 Plan at an exercise price of US$22,75 per share, which shall expire on February 7, 2026. |
· | certain financial institutions; |
· | dealers or traders in securities who use a mark-to-market method of tax accounting; |
· | persons holding common shares as part of a hedging transaction, straddle, wash sale, conversion transaction or other integrated transaction or persons entering into a constructive sale with respect to the common shares; |
· | persons whose functional currency for U.S. federal income tax purposes is not the U.S. dollar; |
· | entities classified as partnerships for U.S. federal income tax purposes; |
· | tax-exempt entities, including an “individual retirement account” or “Roth IRA”; |
· | persons that own or are deemed to own ten percent or more of our shares (by vote or value); |
· | persons who are subject to Section 451(b) of the Code; or |
· | persons holding common shares in connection with a trade or business conducted outside of the United States. |
· | a citizen or individual resident of the United States; |
· | a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the United States, any state therein or the District of Columbia; or |
· | an estate or trust the income of which is subject to U.S. federal income taxation regardless of its source. |
(i) | holders of 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) in the Company under the Dutch Income Tax Act 2001 (Wet inkomstenbelasting 2001). Generally speaking, a holder of securities in a company is considered to hold a substantial interest in such company, if such holder alone or, in the case of 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; |
(ii) | holders of shares if the shares held by such holders qualify or qualified as a participation (deelneming) for purposes of the Dutch Corporate Income Tax Act 1969 (Wet op de vennootschapsbelasting 1969). Generally, a taxpayer’s shareholding of 5% or more in a company’s nominal paid-up share capital (or, in certain cases, in voting rights) qualifies as participation. A holder may also have a participation if such holder does not have a shareholding of 5% or more but a related entity (statutorily defined term) has a participation or if the company in which the shares are held is a related entity (statutorily defined term); |
(iii) | holders of shares who are individuals for whom the shares or any benefit derived from the shares are a remuneration or deemed to be a remuneration for (employment) activities or services performed by such holders or certain individuals related to such holders, whether within or outside an employment relation, that provides the holder, economically speaking, with certain benefits that have a relation to the relevant work activities or services (as defined in the Dutch Income Tax Act 2001); and |
(iv) | pension funds, investment institutions (fiscale beleggingsinstellingen), exempt investment institutions (vrijgestelde beleggingsinstellingen) (as defined in the Dutch Corporate Income Tax Act 1969) and other entities that are, in whole or in part, not subject to or exempt from corporate income tax in the Netherlands, as well as entities that are exempt from corporate income tax in their country of residence, such country of residence being another state of the European Union, Norway, Liechtenstein, Iceland or any other state with which the Netherlands have agreed to exchange information in line with international standards. |
· | 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. |
(i) | the shares are attributable to an enterprise from which the holder of shares derives a share of the profit, whether as an entrepreneur or as a person who has a co-entitlement to the net worth (medegerechtigd tot het vermogen) of such enterprise, without being an entrepreneur or a shareholder in such enterprise, as defined in the Dutch Income Tax Act 2001; or |
(ii) | the holder of shares is considered to perform activities with respect to the 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). |
(i) | such holder does not have an interest in an enterprise or a deemed enterprise (as defined in the Dutch Income Tax Act and the Dutch Corporate Income Tax Act) 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 shares are attributable; and |
(ii) | in the event such holder is an individual, such holder does not carry out any activities in the Netherlands with respect to the shares that go beyond ordinary asset management (normaal, actief vermogensbeheer) and does not derive benefits from the shares that are taxable as benefits from other activities in the Netherlands (resultaat uit overige werkzaamheden). |
(i) | the decedent, the donor, the heir, the donee or any other beneficiary has his /her /its residence, domicile, registered office or place of management in Germany at the time of the transfer, or is a German citizen who has not stayed abroad for more than five consecutive years without having a residence in Germany; or |
(ii) | (irrespective of the personal circumstances) the shares are held by the decedent or donor as business assets for which a permanent establishment in Germany is maintained or a permanent representative is appointed in Germany: or |
(iii) | (irrespective of the personal circumstances) at least 10% of the shares are held directly or indirectly by the decedent or person making the gift, himself or together with a related party in terms of Section 1 paragraph 2 Foreign Tax Act. |
Expenses | Amount (€) | |||
Public offering of security insurance | 583,100 | |||
Legal fees and expenses | 299,927 | |||
Auditing fees and expenses | 252,500 | |||
FINRA filing fee | 18,889 | |||
SEC registration fee | 15,351 | |||
Total | 1,169,767 |
Expenses | Amount (US$) | |||
Legal fees and expenses | 1,608,937 | |||
IPO insurance | 583,100 | |||
Accounting and auditing fees and expenses | 393,263 | |||
NASDAQ listing fee | 107,576 | |||
SEC registration fee | 17,958 | |||
FINRA filing fee | 16,146 | |||
Miscellaneous costs | 2,092 | |||
Total | 2,729,072 |
Exhibit no. | Description | |
Articles of Association of InflaRx N.V. (incorporated herein by reference to Exhibit 3.2 to the post-effective amendment to the Company’s Registration Statement on Form F-1 (File No. 333-220962) filed with the SEC on November 9, 2017). | ||
Registration Rights Agreement (incorporated herein by reference to Exhibit 4.2 to the post-effective amendment to the Company’s Registration Statement on Form F-1 (File No. 333-220962) filed with the SEC on November 9, 2017) | ||
English language summary of Lease Agreement dated January 15, 2008 between InflaRx GmbH and Ernst-Abbe-Stiftung, as amended and supplemented from time to time (incorporated herein by reference to Exhibit 10.1 to the Company’s Registration Statement on Form F-1 (File No. 333-220962) filed with the SEC on October 13, 2017). | ||
English language summary of Lease Agreement dated April 10, 2017 between InflaRx GmbH and Immoprojekt Grundstücksveraltungsgesellschaft mbh (incorporated herein by reference to Exhibit 10.2 to the Company’s Registration Statement on Form F-1 (File No. 333-220962) filed with the SEC on October 13, 2017). | ||
Co-Development Agreement dated December 28, 2015 between InflaRx GmbH and Beijing Defengrei Biotechnology Co. Ltd., as supplemented by Addendum No. 1 dated December 28, 2015 (incorporated herein by reference to Exhibit 10.3 to the Company’s Amendment No. 4 to the Registration Statement on Form F-1 (File No. 333-220962) filed with the SEC on November 7, 2017). | ||
Form of Indemnification Agreement for directors and executive officers (incorporated herein by reference to Exhibit 10.4 to the Company’s Registration Statement on Form F-1 (File No. 333-220962) filed with the SEC on October 13, 2017). | ||
InflaRx Long-Term Incentive Plan (incorporated herein by reference to Exhibit 99 to the Company’s Registration Statement on Form S-8 (File No. 333-221656) filed with the SEC on November 17, 2017). | ||
List of Subsidiaries. | ||
Certification pursuant to section 302 of the Sarbanes-Oxley Act of 2002. | ||
Certification pursuant to section 302 of the Sarbanes-Oxley Act of 2002. | ||
Certification pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 | ||
Certification pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 | ||
Consent of KPMG AG Wirtschaftsprüfungsgesellschaft | ||
101 | The following materials from our Annual Report on Form 20-F for the year ended December 31, 2018 formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Financial Statements and (ii) the Notes to the Consolidated Financial Statements, tagged as blocks of text and in detail. |
* | Filed herewith. |
+ | Previously filed. |
† | Confidential treatment granted as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission. |
InflaRx N.V. | |||
By: | /s/ Niels Riedemann | ||
Name: | Niels Riedemann | ||
Title: | Chief Executive Officer and Director |
By: | /s/ Arnd Christ | ||
Name: | Arnd Christ | ||
Title: | Chief Financial Officer |
Audited Annual Consolidated Financial Statements | Page |
F-2 | |
F-3 | |
F-4 | |
F-5 | |
F-6 | |
F-7 |
Note | 2016 | 2017 | 2018 | |||||||||||
(in thousands of €, except for per share data) | ||||||||||||||
Operating Expenses | ||||||||||||||
Research and development expenses | (5,278 | ) | (14,415 | ) | (25,028 | ) | ||||||||
General and administrative expenses | (1,844 | ) | (5,138 | ) | (12,787 | ) | ||||||||
Total Operating Expenses | 1. (a) | (7,122 | ) | (19,553 | ) | (37,815 | ) | |||||||
Other income | 238 | 116 | 304 | |||||||||||
Other expenses | (7 | ) | (8 | ) | (5 | ) | ||||||||
Operating Result | (6,891 | ) | (19,445 | ) | (37,516 | ) | ||||||||
Finance income | 1 | 130 | 10,433 | |||||||||||
Finance expenses | (2,049 | ) | (4,923 | ) | (2,731 | ) | ||||||||
Net financial Result | 1. (a) | (2,048 | ) | (4,793 | ) | 7,702 | ||||||||
Loss for the period | (8,939 | ) | (24,238 | ) | (29,815 | ) | ||||||||
Share information | 4. (e) | |||||||||||||
Weighted average number of shares outstanding | 2,363 | 9,411 | 25,095 | |||||||||||
Loss per share in euro (basic/diluted) | € | (3.8 | ) | € | (2.6 | ) | € | (1.19 | ) | |||||
Loss for the period | (8,939 | ) | (24,238 | ) | (29,815 | ) | ||||||||
Other comprehensive income that may be reclassified to profit or loss in subsequent periods: | ||||||||||||||
Exchange differences on translation of foreign operations | 1 | 0 | 51 | |||||||||||
Total comprehensive loss | (8,939 | ) | (24,238 | ) | (29,764 | ) |
Note | 2017 | 2018 | ||||||||
(in thousands of €) | ||||||||||
ASSETS | ||||||||||
Non-current assets | ||||||||||
Property, plant and equipment | 173 | 625 | ||||||||
Intangible assets | 41 | 223 | ||||||||
Non-current financial assets | 20 | 207 | ||||||||
Total non-current assets | 234 | 1,055 | ||||||||
Current assets | ||||||||||
Current other assets | 1. (c) | 696 | 1,589 | |||||||
Current financial assets | 1. (d) | 0 | 101,184 | |||||||
Cash and cash equivalents | 1. (f) | 123,282 | 55,386 | |||||||
Total current assets | 123,979 | 158,159 | ||||||||
TOTAL ASSETS | 124,213 | 159,214 | ||||||||
EQUITY AND LIABILITIES | ||||||||||
Equity | 1. (e) | |||||||||
Issued capital | 2,858 | 3,116 | ||||||||
Share premium | 161,639 | 211,022 | ||||||||
Other capital reserves | 6,225 | 18,310 | ||||||||
Accumulated deficit | (51,293 | ) | (81,107 | ) | ||||||
Other components of equity | 0 | 50 | ||||||||
Total equity | 119,429 | 151,391 | ||||||||
Non-current liabilities | ||||||||||
Provisions | 2 | 57 | ||||||||
Government grants | 15 | 11 | ||||||||
Total non-current liabilities | 17 | 68 | ||||||||
Current liabilities | ||||||||||
Employee Benefits | 295 | 788 | ||||||||
Social securities and current other tax liabilities | 2 | 310 | ||||||||
Trade and other payables | 1. (d) | 4,469 | 6,657 | |||||||
Total current liabilities | 4,766 | 7,756 | ||||||||
Total Liabilities | 4,783 | 7,824 | ||||||||
TOTAL EQUITY AND LIABILITIES | 124,213 | 159,214 |
Note | Shares out- standing | Issued capital | Share pre-mium | Other capital reserves | Accumu- lated deficit | Other compo- nents of equity | Total equity | |||||||||||||||||||||||
(in thousands of €, except for share data) | ||||||||||||||||||||||||||||||
Balance at January 1, 2016 | 2,362,500 | 31 | 0 | 457 | (18,116 | ) | 9 | (17,619 | ) | |||||||||||||||||||||
Loss for the period | — | — | — | — | (8,939 | ) | — | (8,939 | ) | |||||||||||||||||||||
Total comprehensive loss | — | — | — | — | (8,939 | ) | — | (8,939 | ) | |||||||||||||||||||||
Transactions with owners of the Company | ||||||||||||||||||||||||||||||
Contributions | ||||||||||||||||||||||||||||||
Equity-settled share-based payment | — | — | — | 868 | — | — | 868 | |||||||||||||||||||||||
Total Contributions | — | — | — | 868 | — | — | 868 | |||||||||||||||||||||||
Total transactions with owners of the Company | — | — | — | 868 | — | — | 868 | |||||||||||||||||||||||
Balance at December 31, 2016 | 2,362,500 | 31 | 0 | 1,325 | (27,055 | ) | 9 | (25,690 | ) | |||||||||||||||||||||
Loss for the period | — | — | — | — | (24,238 | ) | — | (24,238 | ) | |||||||||||||||||||||
Exchange differences on translation of foreign operations | — | — | — | — | — | 0 | 2 | |||||||||||||||||||||||
Total comprehensive loss | — | — | — | — | (24,238 | ) | 0 | (24,238 | ) | |||||||||||||||||||||
Transactions with owners of the Company | ||||||||||||||||||||||||||||||
Contributions | ||||||||||||||||||||||||||||||
Issue of common shares | 1. (e) | 7,068,129 | 848 | 90,055 | — | — | — | 90,903 | ||||||||||||||||||||||
Transaction costs | — | — | (9,115 | ) | — | — | — | (9,115 | ) | |||||||||||||||||||||
Equity-settled share-based payment | 4. (d) | — | — | — | 4,550 | — | — | 4,550 | ||||||||||||||||||||||
Total Contributions | 7,068,129 | 848 | 80,940 | 4,550 | — | — | 86,338 | |||||||||||||||||||||||
Changes in ownership interests | ||||||||||||||||||||||||||||||
Reorganization | 16,482,071 | 1,978 | 80,698 | 350 | — | — | 83,026 | |||||||||||||||||||||||
Liquidation of a Subsidiary | — | — | — | — | — | (9 | ) | (9 | ) | |||||||||||||||||||||
Total changes in ownership interests | 16,482,071 | 1,978 | 80,698 | 350 | — | (9 | ) | 83,017 | ||||||||||||||||||||||
Total transactions with owners of the Company | 23,550,200 | 2,826 | 161,638 | 4,900 | — | (9 | ) | 169,355 | ||||||||||||||||||||||
Balance at December 31, 2017 | 23,812,100 | 2,857 | 161,639 | 6,225 | (51,293 | ) | 0 | 119,429 | ||||||||||||||||||||||
Loss for the period | — | — | — | — | (29,815 | ) | — | (29,815 | ) | |||||||||||||||||||||
Exchange differences on translation of foreign operations | — | — | — | — | — | 51 | 51 | |||||||||||||||||||||||
Total comprehensive loss | — | — | — | — | (29,815 | ) | 51 | (29,764 | ) | |||||||||||||||||||||
Transactions with owners of the Company | ||||||||||||||||||||||||||||||
Contributions | ||||||||||||||||||||||||||||||
Issue of common shares | 1. (e) | 1,850,000 | 222 | 52,769 | — | — | — | 52,991 | ||||||||||||||||||||||
Transaction costs | — | — | (3,801 | ) | — | — | — | (3,801 | ) | |||||||||||||||||||||
Equity-settled share-based payment | 4. (d) | — | — | — | 12,085 | — | — | 12,085 | ||||||||||||||||||||||
Share options exercised | 302,279 | 36 | 416 | — | — | — | 452 | |||||||||||||||||||||||
Total Contributions | 2,152,279 | 258 | 49,384 | 12,085 | — | — | 61,727 | |||||||||||||||||||||||
Total transactions with owners of the Company | 2,152,279 | 258 | 49,384 | 12,085 | — | — | 61,727 | |||||||||||||||||||||||
Balance at December 31, 2018 | 25,964,379 | 3,116 | 211,022 | 18,310 | (81,107 | ) | 50 | 151,391 |
Note | 2016 | 2017 | 2018 | |||||||||||
(in thousands of €) | ||||||||||||||
Operating activities | ||||||||||||||
Loss for the period | (8,939 | ) | (24,238 | ) | (29,815 | ) | ||||||||
Adjustments for: | ||||||||||||||
Depreciation & Amortization | 33 | 71 | 174 | |||||||||||
Net financial result | 1. (a) | 2,048 | 4,793 | (7,702 | ) | |||||||||
Share based payment expense | 4. (d) | 868 | 4,550 | 12,085 | ||||||||||
Effects of exchange rate changes on financial assets | — | (61 | ) | (2,387 | ) | |||||||||
other non-cash adjustments | (2 | ) | 24 | 421 | ||||||||||
Changes in: | ||||||||||||||
Current other assets | (74 | ) | (523 | ) | (894 | ) | ||||||||
Current financial assets | (22 | ) | 154 | (316 | ) | |||||||||
Provisions | 55 | |||||||||||||
Government grants | (4 | ) | (4 | ) | (4 | ) | ||||||||
Employee benefits | 113 | 129 | 493 | |||||||||||
Social securities and current other tax liabilities | 18 | (30 | ) | 310 | ||||||||||
Trade and other payables | 1,181 | 2,917 | 2,188 | |||||||||||
Interest received | 0 | 66 | 1,679 | |||||||||||
Interest paid | (212 | ) | 0 | 0 | ||||||||||
Net cash flows from operating activities | (4,992 | ) | (12,152 | ) | (23,712 | ) | ||||||||
Investing activities | ||||||||||||||
Cash outflow from the purchase of intangible assets, laboratory and office equipment | (53 | ) | (149 | ) | (806 | ) | ||||||||
Cash outflow for the investment in non-current other financial assets | — | (19 | ) | (210 | ) | |||||||||
Proceeds from the disposal of non-current other financial assets | — | — | 22 | |||||||||||
Proceeds from the disposal of current financial assets | — | — | 7,990 | |||||||||||
Purchase of current & non-current financial assets | 1. (d), 2 (b) | — | — | (106,445 | ) | |||||||||
Net cash flows used in investing activities | (53 | ) | (167 | ) | (99,451 | ) | ||||||||
Financing activities | ||||||||||||||
Proceeds from issuance of share capital | — | 90,904 | 53,443 | |||||||||||
Transaction cost from issuance of share capital | — | (9,115 | ) | (3,801 | ) | |||||||||
Proceeds from issuance of preferred shares | 30,860 | 27,012 | — | |||||||||||
Net cash flows from financing activities | 30,860 | 108,801 | 49,642 | |||||||||||
Effect of exchange rate changes | 1 | (2,317 | ) | 5,626 | ||||||||||
Change in cash and cash equivalents | 25,815 | 94,165 | (67,896 | ) | ||||||||||
Cash and cash equivalents at beginning of period | 3,302 | 29,117 | 123,282 | |||||||||||
Cash and cash equivalents at end of period | 1. (f) | 29,117 | 123,282 | 55,386 |
1. | Research and development expenses |
2016 | 2017 | 2018 | ||||||||||
(in thousands of €) | ||||||||||||
Research and development expenses | ||||||||||||
Third-party services | 3,757 | 8,856 | 15,909 | |||||||||
manufacturing | — | * | 5,559 | 4,829 | ||||||||
clinical, pre-clinical | — | * | 3,297 | 11,080 | ||||||||
Personnel expenses | 1,293 | 4,681 | 8,037 | |||||||||
stock-based compensation expense | 302 | 3,071 | 5,256 | |||||||||
Legal and consulting fees | 95 | 643 | 421 | |||||||||
Other expenses | 132 | 235 | 661 | |||||||||
Total | 5,278 | 14,415 | 25,028 |
2. | General and administrative expenses |
2016 | 2017 | 2018 | ||||||||||
(in thousands of €) | ||||||||||||
General and administrative expenses | ||||||||||||
Personnel expenses | 1,134 | 2,948 | 9,147 | |||||||||
stock-based compensation expense | 566 | 1,479 | 6,828 | |||||||||
Legal and consulting fees | 394 | 1,478 | 2,020 | |||||||||
Other expenses | 316 | 712 | 1,619 | |||||||||
Total | 1,844 | 5,138 | 12,787 |
3. | Employee benefits |
2016 | 2017 | 2018 | ||||||||||
(in thousands of €) | ||||||||||||
Employee benefits | ||||||||||||
Wages and salaries | 1,467 | 2,897 | 4,501 | |||||||||
Social Security contributions* | 126 | 182 | 350 | |||||||||
Stock-based compensation expense | 868 | 4,550 | 12,085 | |||||||||
Other | — | — | 248 | |||||||||
Total | 2,462 | 7,629 | 17,184 |
4. | Net Financial Result |
2016 | 2017 | 2018 | ||||||||||
(in thousands of €) | ||||||||||||
Finance income | ||||||||||||
Foreign exchange income | — | — | 8,250 | |||||||||
Interest income | — | 130 | 2,183 | |||||||||
Other | 1 | — | - | |||||||||
Total | 1 | 130 | 10,433 | |||||||||
Finance costs | ||||||||||||
Foreign exchange expense | 3 | 2,358 | 2,624 | |||||||||
Other | 2,046 | 2,565 | 107 | |||||||||
Total | 2,049 | 4,923 | 2,731 | |||||||||
Net financial result | (2,048 | ) | (4,793 | ) | 7,702 |
December 31, 2017 | December 31, 2018 | |||||||
(in thousands of €) | ||||||||
InflaRx N.V. | 7,923 | 33,571 | ||||||
InflaRx GmbH | 34,787 | 34,787 |
2016 | 2017 | 2018 | ||||||||||
(in thousands of €) | ||||||||||||
InflaRx | ||||||||||||
Loss before taxes | (8,939 | ) | (24,238 | ) | (29,815 | ) | ||||||
Tax rate | 30.5 | % | 31.2 | % | 29.2 | % | ||||||
Tax benefits at tax rate | 2,729 | 7,560 | 8,715 | |||||||||
Tax losses for which no deferred tax asset was recognized | (2,729 | ) | (7,560 | ) | (8,715 | ) | ||||||
Income taxes | — | — | — |
December 31, 2017 | December 31, 2018 | |||||||
(in thousands of €) | ||||||||
Current other assets | ||||||||
Prepaid expense | 504 | 1,047 | ||||||
Other | 192 | 542 | ||||||
Total | 696 | 1,589 |
December 31, 2017 | December 31, 2018 | |||||||
(in thousands of €) | ||||||||
Financial assets at amortized cost | ||||||||
Non-current financial assets | 20 | 207 | ||||||
Current financial assets | 0 | 101,184 | ||||||
Financial liabilities at amortized cost | ||||||||
Trade and other payables | (4,469 | ) | (6,657 | ) |
1. | Issue of share capital |
2. | Shares Outstanding |
December 31, 2017 | December 31, 2018 | |||||||
(in thousands of €) | ||||||||
Short-term deposits | ||||||||
Deposits held in U.S. dollars | 81,229 | 32,919 | ||||||
Deposits held in euro | 38,876 | — | ||||||
Total | 120,105 | 32,919 | ||||||
Cash at banks | ||||||||
Money held in euro | 2,842 | 21,720 | ||||||
Money held in U.S. dollars | 335 | 748 | ||||||
Total | 3,177 | 22,468 | ||||||
Total cash and cash equivalents | 123,282 | 55,386 |
2. | Risk |
1. | Financial risk management objectives and policies |
Exposure | Measurement | Risk Management | |
Market risk | Future development costs; Recognized financial assets and liabilities not denominated in euro | Forecasted cash flows Sensitivity analysis | Achievement of a natural hedge in the future |
Credit risk | Cash and cash equivalents, debt investments | Credit rating | Diversification of bank deposits, Investment guidelines for debt investments |
Liquidity | R&D and G&A cost and trade payables | Rolling cash flow forecast | Availability of funds through financing rounds or public offerings |
2. | Market risk |
December 31, 2018 | ||||
Non-current financial assets | 207 | |||
Current financial assets | 101,184 | |||
Cash and cash equivalents | 55,386 | |||
Total assets exposed to the risk | 156,777 | |||
Conversion rate EUR/USD at reporting date 1/1.1450 |
Conversion rate | Profit/(loss) in P&L | carrying amount | ||||||||||
Euro weakens by 1% against U.S. dollars | 1.1565 | (1,552 | ) | 155,225 | ||||||||
Euro strengths by 1% against U.S. dollars | 1.1336 | 1,584 | 158,361 | |||||||||
Euro weakens by 5% against U.S. dollars | 1.2023 | (7,466 | ) | 149,311 | ||||||||
Euro strengths by 5% against U.S. dollars | 1.0878 | 8,251 | 165,028 | |||||||||
Euro weakens by 10% against U.S. dollars | 1.2595 | (14,252 | ) | 142,525 | ||||||||
Euro strengths by 10% against U.S. dollars | 1.0305 | 17,420 | 174,197 |
3. | Credit risk |
4. | Liquidity risk |
December 31, 2017 | December 31, 2018 | |||||||
(in thousands of €) | ||||||||
Cash and cash equivalents | ||||||||
Short-term deposits | 120,105 | 32,919 | ||||||
Cash at banks | 3,177 | 22,468 | ||||||
Total | 123,282 | 55,386 | ||||||
Marketable Securities | ||||||||
Securities and other Investments (current) | — | 100,868 | ||||||
Total | — | 100,868 | ||||||
Other financial assets | ||||||||
Other (non-current portion) | 20 | 207 | ||||||
Other (current) | — | 316 | ||||||
Total | 20 | 523 | ||||||
Total funds available | 123,302 | 156,777 |
3. | Unrecognized items |
December 31, 2017 | December 31, 2018 | |||||||
(in thousands of €) | ||||||||
Commitments for minimum lease payments in relation to non-cancellable operating leases: | ||||||||
Within one year | 244 | 283 | ||||||
After one year but not more than five years | 473 | 292 | ||||||
More than five years | — | — | ||||||
Total | 717 | 575 | ||||||
Rental expense relating to operating leases | ||||||||
Minimum lease payments | 162 | 213 | ||||||
Contingent rentals | — | — | ||||||
Sub-lease income | — | — | ||||||
Total | 162 | 213 |
December 31, 2017 | December 31, 2018 | |||||||
(in thousands of €) | ||||||||
Commitments for minimum payments in relation to non-cancellable operating contracts or services: | ||||||||
Within one year | 4,437 | 19,624 | ||||||
After one year but not more than five years | 88 | 9,684 | ||||||
More than five years | 7 | — | ||||||
Total | 4,532 | 29,307 |
4. | Other information |
Place of business/ country of | Functional | Ownership interest held by the Group | |||||||||||
Name | incorporation | currency | 2017 | 2018 | Principal activities | ||||||||
InflaRx GmbH | Germany | EUR | 100 | % | 100 | % | Principal operating subsidiary, biopharmaceutical company | ||||||
InflaRx Pharmaceutical Inc. | U.S. | USD | — | 100 | % | Subsidiary for basic research |
· | Professor Niels C. Riedemann, Chief Executive Officer (CEO) |
· | Professor Renfeng Guo, Chief Scientific Officer (CSO) |
· | Arnd Christ, Chief Financial Officer (CFO) |
· | Jason Marks, Chief Legal Officer, General Counsel (CLO), since January 1, 2019 |
· | Othmar Zenker, Chief Medical Officer (CMO) |
· | Professor Niels C. Riedemann, CEO |
· | Professor Renfeng Guo, CSO |
· | Nicolas Fulpius, Chairman, Chairman of the Audit Committee |
· | Jens Holstein, since September 21, 2018 Member of the Audit Committee |
· | Anthony Gibney, since February 6, 2018 Member of the Audit Committee |
· | Katrin Uschmann, Member of the Audit Committee until February 6, 2018 |
· | Lina Ma |
· | Mark Kübler, Member of the Audit Committee until September 21, 2018 |
· | Richard Brudnick, Non-Voting Observer Director since February 14, 2019 , subject to the approval at the Annual General Meeting of Shareholders in May 2019. |
2016 | 2017 | 2018 | ||||||||||
(in thousands of €) | ||||||||||||
Executive Management | ||||||||||||
Short-term employee benefits | 604 | 1,987 | 2,524 | |||||||||
Share-based payments | 660 | 3,187 | 9,801 | |||||||||
Total | 1,264 | 5,174 | 12,325 | |||||||||
Non-executive Board of Directors | ||||||||||||
Short-term employee benefits | — | 81 | 238 | |||||||||
Share-based payments | 208 | 43 | 1,086 | |||||||||
Total | 208 | 124 | 1,324 | |||||||||
Total Compensation | 1,472 | 5,298 | 13,649 |
1. | Equity settled share-based payment arrangements |
2018 | ||||
Number of stock options: | ||||
Outstanding at January 1, 2018 | 1,869,192 | |||
Granted in 2018 | 208,073 | |||
Forfeited in 2018 | (26,256 | ) | ||
Outstanding at December 31, 2018 | 2,051,009 | |||
thereof vested | 626,933 | |||
thereof exercised | — |
2. | Stock options exercised |
3. | Measurement of fair values of stock options granted |
Q1-2018 | Q2-2018 | Q3-2018 | Q3-2018 | Q4-2018 | ||||||||||||||||
Parameters | ||||||||||||||||||||
Fair value at grant date | ||||||||||||||||||||
Per option (USD) | 13.79 | 22.37 | 19.80 | 20.17 | 13.39 | |||||||||||||||
FX rate as of grant date | 0.82 | 0.86 | 0.86 | 0.85 | 0.88 | |||||||||||||||
Per option (EUR) | 11.24 | 19.23 | 16.96 | 17.15 | 11.75 | |||||||||||||||
Share price at grant date (USD) | 22.75 | 37.85 | 32.40 | 33.06 | 26.02 | |||||||||||||||
Exercise price (USD) | 22.75 | 37.85 | 32.40 | 33.06 | 26.02 | |||||||||||||||
Expected volatility | 0.73 | 0.73 | 0.73 | 0.73 | 0.65 | |||||||||||||||
Expected life (midpoint based) | 4.9 | 4.6 | 4.9 | 4.9 | 4 | |||||||||||||||
Expected dividends | — | — | — | — | — | |||||||||||||||
Risk-free rate (interpolated, U.S. sovereign strips curve) | 2.6 | % | 2.7 | % | 2.8 | % | 3.0 | % | 2.9 | % |
· | the more options granted within a tranche, the higher expense of a tranche, and |
· | the shorter the vesting period of a tranche, the higher expense of a tranche. |
· | in 2018, €12.1 million resulting solely from the 2017 long-term incentive plan, |
· | in 2017, €0.6 million from the 2017 long-term incentive plan and another €4.0 million resulting from 2016 option plan and the plans before, |
· | In 2016, €0.9 million from 2016 option plan and the plans before. |
1. | Basis of preparation |
2. | New and amended standards adopted by the Group |
· | IFRS 9 Financial Instruments |
· | IFRS 15 Revenue from Contracts with Customers |
· | Amendments to IFRS 2 - Classification and Measurement of Share-based Payments |
· | Annual Improvements 2014-2016 cycle |
· | Transfers to Investment Property – Amendments to IAS 40 |
· | Interpretation 22 Foreign Currency Transactions and Advance Consideration |
3. | New standards and interpretations not yet adopted |
· | IFRIC 23 Uncertainty over Tax Treatments. |
· | Prepayment Features with Negative Compensation (Amendments to IFRS 9). |
· | Long-term Interests in Associates and Joint Ventures (Amendments to IAS 28). |
· | Plan Amendment, Curtailment or Settlement (Amendments to IAS 19). |
· | Annual Improvements to IFRS Standards 2015–2017 Cycle – various standards. |
· | Amendments to References to Conceptual Framework in IFRS Standards. |
· | IFRS 17 Insurance Contracts. |
· | IFRS 16 Leases. |
4. | Current and non-current distinction |
5. | Foreign currency transactions |
6. | Research and development |
7. | Employee benefits |
9. | Government grants |
10. | Lease arrangements |
11. | Interest income |
12. | Intangible assets |
13. | Laboratory and office equipment |
· | Laboratory equipment: three to 13 years |
· | Office equipment: one to five years |
14. | Financial assets and liabilities (financial instruments) |
15. | Income taxes |
16. | Fair Value Measurement |
· | Level 1, quoted prices in active markets for identical assets or liabilities. |
· | Level 2, inputs other than quoted prices included within Level 1 that are observable for the instrument, either directly (as prices) or indirectly (derived from prices). |
· | Level 3, inputs for instruments that are not based on observable market data (unobservable inputs). |
F-25