InflaRx N.V.(IFRX) - 2018 Q4 - Annual Report

PART I Key Information This section presents InflaRx's selected financial data and key risk factors, emphasizing its history of significant operating losses Selected Financial Data The company experienced increasing net losses, reaching €29.8 million in 2018, while total equity turned positive due to capital raises Consolidated Statement of Comprehensive Loss Data (in thousands of €) | | 2016 | 2017 | 2018 | | :--- | :--- | :--- | :--- | | Research and development expenses | (5,278) | (14,415) | (25,028) | | General and administrative expenses | (1,844) | (5,138) | (12,787) | | Loss for the period | (8,939) | (24,238) | (29,815) | | Net loss per common share, basic and diluted (€) | (3.8) | (2.6) | (1.2) | Consolidated Statement of Financial Position Data (in thousands of €) | | 2016 | 2017 | 2018 | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | 29,117 | 123,282 | 55,386 | | Total assets | 29,518 | 124,213 | 159,214 | | Total liabilities | 55,207 | 4,784 | 7,824 | | Total equity | (25,689) | 119,429 | 151,391 | - The company prepares its financial statements under International Financial Reporting Standards (IFRS) as issued by the IASB, not U.S. GAAP[49] Risk Factors The company faces substantial risks, including operating losses, funding needs, IFX-1 dependency, clinical trial failures, and regulatory hurdles - The company has a history of significant operating losses, incurring net losses of €8.9 million, €24.2 million, and €29.8 million for the years 2016, 2017, and 2018, respectively, and expects losses to increase[60] - The company is heavily dependent on the success of its lead product candidate, IFX-1. Any failure in its development, regulatory approval, or commercialization would significantly harm the business[79] - The company's approach of targeting C5a inhibition is novel and unproven, with no currently approved therapy specifically targeting C5a, which may present unforeseen issues or delays in the regulatory pathway[77][78] - The company relies on third parties for manufacturing and to conduct clinical trials. Any failure by these third parties to perform satisfactorily could harm the business and delay development timelines[155][158] - The company believes it is likely that it was a "passive foreign investment company" (PFIC) for U.S. federal income tax purposes in 2018, which could result in adverse U.S. tax consequences for U.S. shareholders[262] Information on the Company This section details InflaRx's focus as a clinical-stage biopharmaceutical company, its IFX-1 pipeline, corporate history, and organizational structure History and Development of the Company InflaRx N.V., founded in 2007, is a clinical-stage biopharmaceutical company focused on C5a inhibitors, with a corporate reorganization in 2017 - The company is a clinical-stage biopharmaceutical firm focused on its proprietary anti-C5a technology to discover and develop inhibitors for autoimmune and inflammatory diseases[283] - In 2017, the company underwent a corporate reorganization, establishing InflaRx N.V. (a Dutch public company) as the holding company for InflaRx GmbH (the German operating subsidiary)[285] Business Overview InflaRx's business centers on its anti-C5a technology, with lead candidate IFX-1 in advanced clinical development for HS, AAV, and PG, facing significant competition Product Candidate Pipeline | Product Candidate | Indication | Discovery | Preclinical | Phase I | Phase II | Phase III | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | IFX-1 | Hidradenitis Suppurativa (HS) | ✔ | ✔ | ✔ | IIb | | | IFX-1 | ANCA-associated Vasculitis (AAV) | ✔ | ✔ | ✔ | Initiating | | | IFX-1 | Pyoderma Gangraenosum (PG) | ✔ | ✔ | ✔ | Initiating | | | IFX-1 | Oncology | ✔ | ✔ | | | | | IFX-2 | Chronic Inflammatory Indications | ✔ | Ongoing | | | | - The lead product candidate, IFX-1, is a first-in-class anti-C5a monoclonal antibody being developed for Hidradenitis Suppurativa (HS), for which a Phase IIb trial enrollment was completed in Q4 2018[283][500] - The company is also developing IFX-1 for ANCA-associated Vasculitis (AAV) and Pyoderma Gangraenosum (PG), with Phase II studies planned or commencing[293][294] - The only approved drug for HS is adalimumab (Humira), marketed by AbbVie. InflaRx faces competition from several other companies developing treatments for HS, AAV, and other complement-mediated diseases[425][429][431] Organizational Structure InflaRx N.V. operates as the parent company with two wholly-owned subsidiaries: InflaRx GmbH in Germany and InflaRx Pharmaceuticals, Inc. in the U.S - The company consists of the registrant, InflaRx N.V., and its two wholly-owned subsidiaries, InflaRx GmbH and InflaRx Pharmaceuticals, Inc[494] Property, Plant and Equipment The company operates from leased facilities, with headquarters in Jena, Germany, and additional leased offices in Munich, Ann Arbor, and New York - The company's headquarters are in Jena, Germany, occupying approximately 7,300 sq. ft. of leased office and lab space. It also leases space in Munich, Germany (~5,900 sq. ft.), Ann Arbor, USA, and New York, USA[495] Operating and Financial Review and Prospects This section analyzes InflaRx's financial condition, highlighting increased operating losses driven by R&D, and discusses liquidity, capital resources, and funding requirements Operating Results InflaRx reported an increased net loss of €29.8 million in 2018, driven by higher R&D and G&A expenses, partially offset by positive financial results Comparison of Operating Results (in thousands of €) | | 2017 | 2018 | | :--- | :--- | :--- | | Research and development expenses | (14,415) | (25,028) | | General and administrative expenses | (5,138) | (12,787) | | Net financial result | (4,793) | 7,702 | | Loss for the period | (24,238) | (29,815) | - Research and development expenses increased by €10.6 million in 2018 compared to 2017, primarily due to a €7.1 million increase in CRO/CMO costs for IFX-1 clinical trials (HS Phase IIb, AAV Phase II) and a €3.4 million increase in employee-related costs[520] - General and administrative expenses rose by €7.7 million in 2018, mainly due to a €6.2 million increase in employee-related costs (salaries, bonuses, share-based compensation) and higher legal and consulting fees related to the follow-on offering[521] - Net financial result improved by €12.5 million to a gain of €7.7 million in 2018, largely attributable to €8.3 million in foreign exchange gains from U.S. dollar-denominated assets[522] Liquidity and Capital Resources As of December 31, 2018, the company held €55.4 million in cash and €101.0 million in marketable securities, but anticipates significant additional funding needs for future clinical trials - As of December 31, 2018, the company held €55.4 million in cash and cash equivalents and €101.0 million in marketable securities[531] Consolidated Statement of Cash Flows Summary (in thousands of €) | | 2017 | 2018 | | :--- | :--- | :--- | | 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 | - The company expects to require substantial additional funding for its continuing operations, particularly for the planned Phase III clinical trial of IFX-1 in HS, which is estimated to cost between €40 to €50 million[542] Contractual Obligations As of December 31, 2018, total contractual obligations were €29.9 million, primarily from CRO commitments and non-cancellable operating contracts Contractual Obligations as of December 31, 2018 (in thousands of €) | | Total | Less than 1 year | Between 1 and 3 Years | Between 3 and 5 Years | More than 5 years | | :--- | :--- | :--- | :--- | :--- | :--- | | Contractual CRO commitments and other | 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 | Directors, Senior Management and Employees This section details the company's board of directors, senior management, employee information, compensation structure, and board committee responsibilities Directors and Senior Management The company's leadership includes co-founders Niels Riedemann (CEO) and Renfeng Guo (CSO), with a board chaired by Nicolas Fulpius - The board of directors includes co-founders Niels Riedemann (CEO) and Renfeng Guo (CSO) as executive directors, and Nicolas Fulpius as Chairman[551][553][561][562] Compensation In 2018, senior management compensation totaled €12.3 million, with non-executive directors receiving €1.3 million, including equity awards - Aggregate compensation for senior management in 2018 was €12,325 thousand, while non-executive directors received €1,324 thousand[568][570] - The 2017 Equity Incentive Plan was established with an initial maximum of 2,341,097 common shares available for issuance, plus an annual evergreen provision of 3% of outstanding shares[575] Board Practices The board of directors, comprising eight members, has established key committees and follows home country governance practices as a foreign private issuer - The board has three main committees: Audit, Compensation, and Nomination and Corporate Governance[584][588][591] - As a foreign private issuer, the company opts out of certain NASDAQ corporate governance requirements, including having a majority of independent directors, a fully independent compensation committee, and independent director oversight of nominations[582] Employees As of December 31, 2018, InflaRx had 38 employees, with 14 holding M.D. or Ph.D. degrees, maintaining positive employee relations - The company had 38 employees as of December 31, 2018[592] Major Shareholders and Related Party Transactions This section details the beneficial ownership of common shares, concentrated among institutional investors and management, and notes indemnification agreements Major Shareholders As of March 12, 2019, major shareholders include several institutional investors with over 5% beneficial ownership, and directors and senior management collectively owned 18.8% Beneficial Ownership of 5% Shareholders (as of March 12, 2019) | Shareholder | Percent of Shares | | :--- | :--- | | Adage Capital Partners GP, L.L.C. | 10.3% | | Entities affiliated with Staidson Hong Kong Investment Company Limited | 8.9% | | Entities affiliated with RA Capital Management, LLC | 8.0% | | Redmile Group, LLC | 7.8% | | Bain Capital Life Sciences Investors, LLC | 6.8% | | Cormorant Asset Management, LP | 5.7% | | Entities affiliated with Private Equity Thüringen GmbH & Co | 5.2% | - All directors and senior management as a group beneficially owned 18.8% of the company's common shares[596] Financial Information This section confirms the inclusion of audited IFRS financial statements and states the company has no material legal proceedings or plans for cash dividends Consolidated Statements and Other Financial Information The company's audited financial statements are included, and it has no plans to pay cash dividends, intending to retain all earnings for business growth - The company has never paid or declared cash dividends and does not plan to in the foreseeable future, intending to retain all earnings for business development[613] Additional Information This section provides details on corporate governance, material contracts, and significant U.S., Dutch, and German tax consequences for shareholders Taxation This section details material U.S., Dutch, and German tax consequences for shareholders, including the company's likely PFIC status for U.S. tax purposes - The company believes it is likely that it was a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes in 2018, which may subject U.S. Holders to adverse tax consequences[640] - As long as the company's place of management remains in Germany, it will not be required to withhold Dutch dividend withholding tax, except for Dutch resident holders[657] - Dividends distributed by the company are subject to German withholding tax at a rate of 25% plus a 5.5% solidarity surcharge, for a total of 26.375%[677] Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk stems from currency exchange rate fluctuations, particularly USD against EUR, with no hedging arrangements currently in place - The company's main market risk is from currency exchange rate fluctuations, particularly as its exposure to the U.S. Dollar increases. No hedging arrangements are currently in place[733] PART II Material Modifications to the Rights of Security Holders and Use of Proceeds This section details the use of proceeds from the company's 2017 IPO ($96 million) and 2018 follow-on offering (€49.2 million) Use of Proceeds The company raised €49.2 million from a May 2018 offering and $96 million from a November 2017 IPO, using €14.4 million for IFX-1 development and G&A - In May 2018, the company completed a follow-on public offering, raising net proceeds of €49.2 million after deducting underwriting discounts and commissions[746][747] - The November 2017 initial public offering raised net proceeds of approximately $96 million after deducting discounts, commissions, and other expenses[749] - Through December 31, 2018, the company used approximately €14.4 million (€2.8 million in 2017 and €11.6 million in 2018) of the net proceeds from its offerings to fund IFX-1 development and for general and administrative costs[751] Controls and Procedures This section confirms the effectiveness of the company's disclosure controls and internal control over financial reporting as of December 31, 2018 Disclosure Controls and Procedures As of December 31, 2018, management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level - The CEO and CFO concluded that as of December 31, 2018, the company's disclosure controls and procedures are effective to provide reasonable assurance that required information is recorded, processed, and reported in a timely manner[753] Management's Annual Report on Internal Control over Financial Reporting Management concluded that the company's internal control over financial reporting was effective as of December 31, 2018, based on the COSO framework - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2018[754] PART III Financial Statements This section presents the audited consolidated financial statements for InflaRx N.V. for 2016-2018, prepared in conformity with IFRS Consolidated Statement of Comprehensive Loss (in thousands of €) | | 2016 | 2017 | 2018 | | :--- | :--- | :--- | :--- | | Research and development expenses | (5,278) | (14,415) | (25,028) | | General and administrative expenses | (1,844) | (5,138) | (12,787) | | Net financial Result | (2,048) | (4,793) | 7,702 | | Loss for the period | (8,939) | (24,238) | (29,815) | Consolidated Statement of Financial Position (in thousands of €) | | Dec 31, 2017 | Dec 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | 123,282 | 55,386 | | Current financial assets | 0 | 101,184 | | Total Assets | 124,213 | 159,214 | | Total Equity | 119,429 | 151,391 | | Total Liabilities | 4,783 | 7,824 | Consolidated Statement of Cash Flows (in thousands of €) | | 2016 | 2017 | 2018 | | :--- | :--- | :--- | :--- | | Net cash flows from operating activities | (4,992) | (12,152) | (23,712) | | Net cash flows used in investing activities | (53) | (167) | (99,451) | | Net cash flows from financing activities | 30,860 | 108,801 | 49,642 |