UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORTOF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of August
Commission File Number:
(Translation of registrant's name into English)
WinzerlaerStr. 2
07745 Jena, Germany
(Address of principal executive office)
Indicate by check mark whether the registrant filesor will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒Form 40-F ☐
EXPLANATORY NOTE
Exhibits 99.1 and 99.2 to this report on Form 6-K(the “Report”) shall be deemed to be incorporated by reference into (i) the registration statements on Form S-8 (File No.333-221656 and 333-240185) and (ii) the registration statement on Form F-3 (File No. 333-273058) of InflaRx N.V. and to be a part thereoffrom the date on which this Report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit 99.3 to this Report shall not be deemed “filed”for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section,nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended
1
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | InflaRx N.V. Unaudited Condensed Consolidated Financial Statements as of and for the Six Months Ended June 30, 2025 | |
| 99.2 | InflaRx N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations | |
| 99.3 | InflaRx N.V. Press Release dated August 7, 2025 | |
| 101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embeddedwithin the Inline XBRL document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
2
SIGNATURES
Pursuant to the requirements of the SecuritiesExchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| INFLARX N.V. | ||
| Date: August 7, 2025 | By: | /s/ Niels Riedemann |
| Name: | Niels Riedemann | |
| Title: | Chief Executive Officer | |
3
Exhibit 99.1
INFLARX N.V.
UNAUDITED CONDENSEDCONSOLIDATED
FINANCIAL STATEMENTS– JUNE 30, 2025
These unaudited condensedfinancial statements are consolidated financial statements for the group consisting of InflaRx N.V. and its wholly-owned subsidiariesInflaRx GmbH, Jena, Germany, and InflaRx Pharmaceuticals Inc., Ann Arbor, Michigan, United States (together, the “Group”).The financial statements are presented in euros (€).
InflaRx N.V. is a companylimited by shares, incorporated and domiciled in Amsterdam, The Netherlands.
Its registered office andprincipal place of business is in Germany, 07745 Jena, Winzerlaer Str. 2
Index to unaudited condensed consolidated financial statementsfor the three and six months ended June 30, 2025
F-2
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statementsof operations and comprehensive loss for the three and six months ended June 30, 2025 and 2024
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||||||
| Note | 2025 (unaudited) | 2024 (unaudited) | 2025 (unaudited) | 2024 (unaudited) | ||||||||||||||||
| (in €, except for share data) | ||||||||||||||||||||
| Revenues | 2 | |||||||||||||||||||
| Cost of sales | 3 | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||
| Gross profit (loss) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Sales and marketing expenses | 4 | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||
| Research and development expenses | 5 | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||
| General and administrative expenses | 6 | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||
| Other income | 7 | |||||||||||||||||||
| Other expenses | ( | ) | ||||||||||||||||||
| Operating result | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Finance income | 8 | |||||||||||||||||||
| Finance expenses | 8 | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||
| Foreign exchange result | 8 | ( | ) | ( | ) | |||||||||||||||
| Other financial result | 8 | |||||||||||||||||||
| Income taxes | ||||||||||||||||||||
| Income (loss) for the period | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | ||||||||||||||||||||
| Exchange differences on translation of foreign currency | ( | ) | ( | ) | ||||||||||||||||
| Total comprehensive income (loss) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Share information | ||||||||||||||||||||
| Weighted average number of shares outstanding | ||||||||||||||||||||
| Income (loss) per share (basic/diluted) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
The accompanying notes are an integral part ofthese condensed consolidated financial statements.
F-3
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statementsof financial position as of June 30, 2025 and December 31, 2024
| Note | June 30, 2025 (unaudited) | December 31, 2024 | ||||||||||
| (in €) | ||||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Property and equipment | ||||||||||||
| Right-of-use assets | ||||||||||||
| Intangible assets | ||||||||||||
| Other assets | 10 | |||||||||||
| Financial assets | 12 | |||||||||||
| Total non-current assets | ||||||||||||
| Current assets | ||||||||||||
| Inventories | 9 | |||||||||||
| Current other assets | 10 | |||||||||||
| Other assets from government grants and research allowance | 10 | |||||||||||
| Tax receivables | 11 | |||||||||||
| Financial assets | 12 | |||||||||||
| Cash and cash equivalents | 14 | |||||||||||
| Total current assets | ||||||||||||
| TOTAL ASSETS | ||||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 15 | |||||||||||
| Share premium | ||||||||||||
| Other capital reserves | ||||||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||||||
| Other components of equity | ||||||||||||
| Total equity | ||||||||||||
| Non-current liabilities | ||||||||||||
| Lease liabilities | ||||||||||||
| Other liabilities | 13 | |||||||||||
| Total non-current liabilities | ||||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 12 | |||||||||||
| Lease liabilities | ||||||||||||
| Employee benefits | ||||||||||||
| Liabilities to warrant holders | ||||||||||||
| Other liabilities | 13 | |||||||||||
| Total current liabilities | ||||||||||||
| Total Liabilities | ||||||||||||
| TOTAL EQUITY AND LIABILITIES | ||||||||||||
The accompanying notes are an integral part ofthese condensed consolidated financial statements.
F-4
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statementsof changes in shareholders’ equity for the six months ended June 30, 2025 and 2024
| (in €, except for share data) | Note | Shares outstanding | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other compo- nents of equity | Total equity | ||||||||||||||||||||||||
| Balance as of January 1, 2025 | ( | ) | ||||||||||||||||||||||||||||||
| Loss for the period | — | ( | ) | ( | ) | |||||||||||||||||||||||||||
| Exchange differences on translation of foreign currency | — | ( | ) | ( | ) | |||||||||||||||||||||||||||
| Total comprehensive loss | — | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Issuance of ordinary shares | ||||||||||||||||||||||||||||||||
| Transaction costs for ordinary shares | — | ( | ) | ( | ) | |||||||||||||||||||||||||||
| Equity-settled share-based payments | 16 | — | ||||||||||||||||||||||||||||||
| Balance as of June 30, 2025 | ( | ) | ||||||||||||||||||||||||||||||
| Balance as of January 1, 2024 | ( | ) | ||||||||||||||||||||||||||||||
| Loss for the period | — | ( | ) | ( | ) | |||||||||||||||||||||||||||
| Exchange differences on translation of foreign currency | — | |||||||||||||||||||||||||||||||
| Total comprehensive loss | — | ( | ) | ( | ) | |||||||||||||||||||||||||||
| Equity-settled share-based payments | 16 | — | ||||||||||||||||||||||||||||||
| Balance as of June 30, 2024 | ( | ) | ||||||||||||||||||||||||||||||
| * | unaudited |
The accompanying notes are an integral part ofthese condensed consolidated financial statements.
F-5
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statementsof cash flows for the six months ended June 30, 2025 and 2024
| For the six months ended June 30, | ||||||||||||
| Note | 2025 (unaudited) | 2024 (unaudited) | ||||||||||
| (in €) | ||||||||||||
| Operating activities | ||||||||||||
| Loss for the period | ( | ) | ( | ) | ||||||||
| Adjustments for: | ||||||||||||
| Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | ||||||||||||
| Net finance income | 8 | ( | ) | ( | ) | |||||||
| Share-based payment expense | 16 | |||||||||||
| Net foreign exchange differences and other adjustments | ( | ) | ||||||||||
| Changes in: | ||||||||||||
| Other assets from government grants and research allowances | ( | ) | ||||||||||
| Other assets and trade receivables | 10 | ( | ) | |||||||||
| Employee benefits | ( | ) | ( | ) | ||||||||
| Other liabilities | 13 | ( | ) | |||||||||
| Trade and other payables | 13 | ( | ) | ( | ) | |||||||
| Inventories | 9 | |||||||||||
| Interest received | 10 | |||||||||||
| Interest paid | ( | ) | ( | ) | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||||||
| Investing activities | ||||||||||||
| Purchase of intangible assets, property and equipment | ( | ) | ( | ) | ||||||||
| Purchase of current financial assets | ( | ) | ( | ) | ||||||||
| Proceeds from the maturity of financial assets | ||||||||||||
| Net cash from / (used in) investing activities | ( | ) | ||||||||||
| Financing activities | ||||||||||||
| Proceeds from issuance of ordinary shares | ||||||||||||
| Proceeds from pre-funded warrants | ||||||||||||
| Transaction costs from issuance of ordinary shares and pre-funded warrants | ( | ) | ||||||||||
| Repayment of lease liabilities | ( | ) | ( | ) | ||||||||
| Net cash from / (used in) financing activities | ( | ) | ||||||||||
| Net increase/decrease in cash and cash equivalents | ( | ) | ||||||||||
| Effect of exchange rate changes on cash and cash equivalents | ( | ) | ||||||||||
| Cash and cash equivalents at beginning of period | ||||||||||||
| Cash and cash equivalents at end of period | 14 | |||||||||||
The accompanying notes are an integral part ofthese condensed consolidated financial statements.
F-6
InflaRx N.V. and subsidiaries
Notes to the unaudited condensed consolidatedfinancial statements
| 1. | Summary of significant accounting policies and other disclosures |
| a) |
InflaRx N.V. (the “Company” or “InflaRx”)is a Dutch public company with limited liability (naamloze vennootschap) with its corporate seat in Amsterdam, the Netherlands,and is registered in the Commercial Register of the Netherlands Chamber of Commerce Business Register under CCI number 68904312. The Company’sregistered office is at Winzerlaer Straße 2 in 07745 Jena, Germany. Since November 10, 2017, InflaRx N.V.’s ordinary shareshave been listed on the Nasdaq Global Select Market under the symbol IFRX.
| b) | Basis of preparation |
These interim condensed consolidated financialstatements for the six-month reporting period ended June 30, 2025, and 2024 have been prepared in accordance with IAS 34 Interim FinancialReporting. These condensed consolidated financial statements do not include all the information and disclosures required in the annualfinancial statements. Accordingly, this report is to be read in conjunction with the financial statements in the Company’s annualreport for the year ended December 31, 2024 on Form 20–F.
The interim condensed consolidated financialstatements were authorized for issue by the board of directors of the Company (the “Board of Directors”) on August 6, 2025.
The financial statements are presented in euros(€). The euro is the functional currency of InflaRx N.V. and InflaRx GmbH. The functional currency of InflaRx Pharmaceuticals Inc.is the U.S. dollar.
All financial information presented in euroshave been rounded to the nearest euro. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregationof the figures that precede them or may deviate from other tables.
The accounting policies adopted are consistentwith those followed in the preparation of the Group’s annual consolidated financial statements for the year ended December 31, 2024,except for the adoption of new standards effective as of January 1, 2025, as set out below. The Group has not adopted any other standard,interpretation or amendment that has been issued but is not yet effective early.
The following amendments were adopted effectiveJanuary 1, 2025, and do not have a material impact on the consolidated financial statements of the Group:
| ● | Amendments to IAS 21 Effects of Changes in Foreign ExchangeRates: Lack of exchangeability |
The following standards issued will be adoptedin a future period, and the potential impact, if any, they will have on the Group’s consolidated financial statements is being assessed:
| ● | Amendments to IFRS 9 Financial Instruments and IFRS 7 FinancialInstruments: Disclosures, Classification and Measurement of Financial Instruments |
| ● | Amendments to IFRS 9 Financial Instruments and IFRS 7 FinancialInstruments: Disclosures, Contracts Referencing Nature-dependent Electricity |
F-7
| 2. | Revenues |
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 (unaudited) | 2024 (unaudited) | 2025 (unaudited) | 2024 (unaudited) | |||||||||||||
| (in €) | ||||||||||||||||
| Revenues | ||||||||||||||||
| Total | ||||||||||||||||
For the three months ended June 30, 2025 and 2024,the Company realized revenues from product sales of GOHIBIC (vilobelimab) in the amount of €
For the six months ended June 30, 2025 and 2024,the Company realized revenues from product sales of GOHIBIC (vilobelimab) in the amount of €
Revenues reported are sales to end customers (hospitals).Sales to distributors do not constitute revenue for the Company under IFRS 15. All revenues are attributed to sales made in the UnitedStates.
| 3. | Cost of sales |
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 (unaudited) | 2024 (unaudited) | 2025 (unaudited) | 2024 (unaudited) | |||||||||||||
| (in €) | ||||||||||||||||
| Cost of sales | ||||||||||||||||
| Total | ||||||||||||||||
For the three months ended June 30, 2025 and 2024,the Company’s cost of sales amounted to €
For the six months ended June 30, 2025 and 2024,the Company’s cost of sales amounted to €
Cost of sales primarily includes write-downs ofunfinished goods held in inventory that exceed expected sales quantities and are likely to expire before they can be sold.
| 4. | Sales and marketing expenses |
During the three months ended June 30, 2025, theGroup incurred €
During the six months ended June 30, 2025, theGroup incurred €
| 5. | Research and development expenses |
During the three months ended June 30, 2025, theGroup incurred €
During the six months ended June 30, 2025, theGroup incurred €
F-8
| 6. | General and administrative expenses |
During the three months ended June 30, 2025, theGroup incurred €
During the six months ended June 30, 2025, theGroup incurred €
| 7. | Other income |
Other income for the three months ended June30, 2025 amounted to €
Other income for the six months ended June 30,2025 amounted to €
During the first six months ended June 30, 2024,the Group did not record other income from research allowances.
| 8. | Net financial result |
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 (unaudited) | 2024 (unaudited) | 2025 (unaudited) | 2024 (unaudited) | |||||||||||||
| (in €) | ||||||||||||||||
| Interest income | ||||||||||||||||
| Interest expenses | ( | ) | ( | ) | ( | ) | ||||||||||
| Interest on lease liabilities | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Financial result | ||||||||||||||||
| Foreign exchange income | ||||||||||||||||
| Foreign exchange expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Foreign exchange result | ( | ) | ( | ) | ||||||||||||
| Result of expected credit loss adjustment on marketable securities | ||||||||||||||||
| Result from the revaluation of pre-funded warrants at fair value | ||||||||||||||||
| Other financial result | ||||||||||||||||
| Net financial result | ( | ) | ||||||||||||||
For the three months ended June 30, 2025, netfinancial result decreased by €
F-9
For the six months ended June 30, 2025, net financialresult decreased by €
| 9. | Inventory |
| As of June 30, 2025 (unaudited) | As of December 31, 2024 | |||||||
| (in €) | ||||||||
| Raw material and supplies | ||||||||
| Unfinished goods | ||||||||
| Finished goods | ||||||||
| Total | ||||||||
As of June 30, 2025, inventory amounted to €
| 10. | Other assets |
| As of June 30, 2025 (unaudited) | As of December 31, 2024 | |||||||
| (in €) | ||||||||
| Non-current other assets | ||||||||
| Prepaid expenses | ||||||||
| Total | ||||||||
| Current other assets | ||||||||
| Prepayments on research & development projects | ||||||||
| Prepaid expenses | ||||||||
| Others | ||||||||
| Total | ||||||||
| Total other assets | ||||||||
| Other assets from research allowances | ||||||||
| Current other assets from research allowances | ||||||||
| Other assets from research allowances | ||||||||
F-10
As of June 30, 2025, prepayments on researchand development projects amounted to €
Prepaid expenses consist mainly of prepaid D&Oinsurance expense for the year 2025, which will be recognized into general and administrative expenses pro rata over the year.
As of June 30, 2025, other assets from researchallowances were €
| 11. | Tax receivables |
As of June 30, 2025, tax receivables amountedto €
| 12. | Financial assets and financial liabilities |
Set out below is an overview of financial assetsand liabilities, other than cash and cash equivalents, held by the Group as of June 30, 2025 and December 31, 2024:
| As of June 30, 2025 (unaudited) | As of December 31, 2024 | |||||||
| (in €) | ||||||||
| Financial assets at amortized cost | ||||||||
| Non-current financial assets | ||||||||
| thereof marketable securities | ||||||||
| Current financial assets | ||||||||
| thereof marketable securities | ||||||||
| Financial liabilities at amortized cost | ||||||||
| Trade and other payables | ||||||||
| Financial liabilities at fair value | ||||||||
| Non-current liabilities to shareholders | ||||||||
In February 2025, the Company issued
As of June 30, 2025, the fair value of currentand non-current financial assets (primarily quoted debt securities) amounted to €
As of June 30, 2025, current and non-current financialassets increased by €
As of June 30, 2025, trade and other payablesdecreased by €
F-11
| 13. | Other liabilities |
| As of June 30, 2025 (unaudited) | As of December 31, 2024 | |||||||
| (in €) | ||||||||
| Accrued liabilities from R&D projects | ||||||||
| Accrued liabilities from commercial activities | ||||||||
| Accounts payable | ||||||||
| Other accrued liabilities and payables | ||||||||
| Total | ||||||||
Accrued liabilities from R&D projects includethird party services from the Company’s ongoing R&D projects that have not yet been invoiced to the Company as of the reportingdate.
| 14. | Cash and cash equivalents |
| As of June 30, 2025 (unaudited) | As of December 31, 2024 | |||||||
| (in €) | ||||||||
| Short-term deposits | ||||||||
| Deposits held in U.S. dollars | ||||||||
| Deposits held in euros | ||||||||
| Total | ||||||||
| Cash at banks | ||||||||
| Cash held in U.S. dollars | ||||||||
| Cash held in euros | ||||||||
| Total | ||||||||
| Total cash and cash equivalents | ||||||||
As of June 30, 2025, cash and cash equivalentsdecreased by €
| 15. | Equity |
On June 30, 2023, the Company filed a Form F-3,or the 2023-Registration Statement, with the Securities Exchange Commission, or the SEC, with respect to the offer and sale of securitiesof the Company, which became effective on July 11, 2023. The aggregate initial offering price of the securities that the Company may offerand sell under this prospectus will not exceed $
In the six months ended June 30, 2025, we issued
In February 2025, the Company completed an underwrittenpublic offering of
F-12
| 16. | Share-based payments |
| a) | Equity settled share-based payment arrangements |
InflaRx GmbH granted options under the 2012 StockOption Plan. Those InflaRx GmbH options were converted into options for ordinary shares of InflaRx N.V. at the time of its IPO in November2017:
| Number of share options | 2025 | 2024 | ||||||
| Outstanding as of January 1, | ||||||||
| Exercised during the six months ended June 30 | ||||||||
| Outstanding as of June 30, | ||||||||
| thereof vested / exercisable | ||||||||
Under the terms and conditions of the share optionplan 2016, InflaRx GmbH granted rights to subscribe for InflaRx GmbH’s ordinary shares to directors, senior management, and keyemployees.
| Number of share options | 2025 | 2024 | ||||||
| Outstanding as of January 1, | ||||||||
| Exercised during the six months ended June 30 | ||||||||
| Outstanding as of June 30, | ||||||||
| thereof vested / exercisable | ||||||||
InflaRx also granted share options under the2017 Long-Term Incentive Plan, or 2017 LTIP, subsequently to its IPO in November 2017. Certain stock options granted between 2017 and2020 were issued with an eight-year option term and during the three months ended March 31, 2025, were extended to an option term of tenyears. The total number of share options granted during the six months ended June 30, 2025 under the 2017 LTIP was as follows:
| Number of share options | 2025 | 2024 | ||||||
| Outstanding as of January 1, | ||||||||
| Granted during the six months ended June 30, | ||||||||
| Exercised during the six months ended June 30, | ||||||||
| Forfeited during the six months ended June 30, | ( | ) | ( | ) | ||||
| Outstanding as of June 30, | ||||||||
| thereof vested / exercisable | ||||||||
The key information and assumptions related toshare options granted during the six months ended June 30, 2025 under the 2017 LTIP were as follows:
| Share options granted 2025 | Number | Fair value per option | FX rate as of grant date | Fair value per option | Share price at grant date / Exercise price | Expected volatility | Expected life (midpoint based) | Risk-free rate (interpolated, U.S. sovereign strips curve) | ||||||||||||||||||||||||
| January 03 | $ | € | $ | |||||||||||||||||||||||||||||
Of the
F-13
Expected dividends are for all shareoptions listed above.
| b) | Share-based payment expense recognized |
For the three months ended June 30, 2025, theCompany has recognized €
For the six months ended June 30, 2025, the Companyhas recognized €
None of the share-based payment awards were dilutivein determining earnings per share due to the Group’s loss position.
| c) | Share options exercised |
During the six months ended June 30, 2025, shares (2024: ) were issued upon the exercise of share options, resulting in no proceeds to the Company (ended June 30, 2024: ).
| 17. | Protective foundation |
According to the articles of association of theCompany, up to
In order to deter acquisition bids, the Company’sgeneral meeting of shareholders approved the right of an independent foundation under Dutch law, or protective foundation, to exercisea call option pursuant to the call option agreement, upon which preferred shares will be issued by the Company to the protective foundationof up to
These preferred shares will have both a liquidationand dividend preference over the Company’s ordinary shares and will accrue cash dividends at a pre-determined rate. The protectivefoundation would be expected to require the Company to cancel its preferred shares once the perceived threat to the Company and its stakeholdershas been removed or sufficiently mitigated or neutralized. The Company believes that the call option does not represent a significantfair value based on a level 3 valuation since the preferred shares are restricted in use and can be cancelled by the Company.
During the three months ended June 30, 2025,the Company expensed €
During the six months ended June 30, 2025, theCompany expensed €
F-14
Exhibit 99.2
MANAGEMENT’SDISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This management’s discussion and analysisis designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you readthis discussion together with our unaudited interim condensed consolidated financial statements, including the notes thereto, for thethree and six months ended June 30, 2025 and 2024, respectively, included as Exhibit 99.1 to the report on Form 6-K to which this discussionis attached as Exhibit 99.2. We also recommend that you read our “ITEM 5. Operating and financial review and prospects” andour audited consolidated financial statements for fiscal year 2024, and the notes thereto, which appear in our annual report on Form 20-Ffor the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission, or the SEC, on March 20,2025. In addition,we recommend that you read any public announcements made by InflaRx N.V.
The following discussion is based on our financialinformation prepared in accordance with IFRS as issued by the IASB, which may differ in material respects from generally accepted accountingprinciples in the United States and other jurisdictions. We maintain our books and records in euros. Unless otherwise indicated, all referencesto currency amounts in this discussion are in euros. We have made rounding adjustments to some of the figures included in this discussionand analysis. Accordingly, numerical figures shown as totals in some tables may not be arithmetic aggregations of the figures that precedethem.
The following discussion includes forward-lookingstatements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in theseforward-looking statements as a result of many factors, including but not limited to those described under “ITEM 3. Key Information––Riskfactors” in the annual report and risks described in our subsequent SEC filings.
Unless otherwise indicated or the context otherwiserequires, all references to “InflaRx” or the “Company,” “we,” “our,” “ours,”“us” or similar terms refer to InflaRx N.V. and its subsidiaries InflaRx GmbH and InflaRx Pharmaceuticals, Inc.
Overview
InflaRx(Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5areceptor technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factorC5a and its receptor. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases.InflaRx has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively bindsto free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies. InflaRx is also developingINF904, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor.
Vilobelimab for the treatment ofPG
In May 2025, we announced that the IndependentData Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for vilobelimab in pyoderma gangrenosum(PG), recommended that the trial be stopped due to futility. This recommendation was based on data analysis of the first 30 patients enrolledin the study, with no unexpected adverse events noted by the IDMC. We are in the process of winding down the clinical study and expectto be able to analyze and to comment on the study results once it is unblinded in due course.
Vilobelimab for the treatment ofsevere COVID-19
In April 2023, we received an EUA, from FDA forGOHIBIC (vilobelimab) for the treatment of COVID-19 in critically ill, invasively mechanically ventilated hospitalized adult patients.The EUA is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, which demonstrated a relative reductionin 28-day all-cause mortality by 23.9%. Subsequently, in June 2023, we began the commercialization of GOHIBIC (vilobelimab) in the UnitedStates under the EUA. In January 2025, the EC granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab)for the treatment of adult patients with SARS-CoV-2-induced ARDS who are receiving systemic corticosteroids as part of standard of careand receiving invasive mechanical ventilation with or without extracorporeal membrane oxygenation.
GOHIBIC (vilobelimab) for ARDS
In June 2025, BARDA announced enrollment of thefirst patient in the JUST BREATHE Phase 2 platform clinical trial investigating novel therapeutic candidates for ARDS. The clinical trialis being implemented by the PPD clinical research business of Thermo Fisher Scientific and aims to evaluate the safety and efficacy ofthree host-directed therapeutic candidates at up to 60 U.S. sites, targeting a total enrollment of 600 hospitalized adult patients withARDS.
Anti-C5aR inhibitor INF904
To expand the breadth of our anti-C5a/C5aR technologies,we are also developing INF904, a product candidate that targets the C5a receptor. In INF904, we discovered a small molecule C5aR inhibitorthat in pre-clinical studies has shown potential for superior characteristics to the only approved C5aR inhibitor, avacopan. INF904 hasprovided higher plasma exposure in animals, including non-human primates, and improved inhibitory activity in a hamster neutropenia modelcompared to avacopan. Furthermore, in contrast to avacopan, in vitro experiments showed INF904 has substantially less inhibition of thecytochrome P450 enzymes 3A4/5 (CYP3A4/5). INF904 demonstrated potential for anti-inflammatory therapeutic effects in several preclinicaldisease models. In January 2024, we announced the positive results of a single and multiple ascending dose study with INF904 in healthyvolunteers. In December 2024, we announced that the first patient was dosed in the Phase 2a basket study in chronic spontaneous urticaria,or “CSU”, and hidradenitis suppurative, or “HS”, with data from five of six dosing cohorts anticipated by theend of September to early November. In May 2025, we announced the successful completion of the required sub-chronic and chronic toxicologystudies for INF904. No safety signals of concern were identified, supporting the potential for long-term dosing in future clinical efforts.Additional required non-clinical studies remain ongoing as planned. INF904 is a promising product candidate for being developed in severaldisease areas of inflammation, where orally available therapeutics are not available or a medical need exists despite availability ofother therapies.
INF904 for the treatment of CSU
We are pursuing development of INF904 for thetreatment of CSU in a Phase 2a trial. CSU is a debilitating and unpredictable skin disease characterized by intensely itchy hives / whealsand angioedema. The burden of this chronic disease is high and impacts sleep, mental health, quality of life and productivity due to absencesfrom school and work. CSU is estimated to affect around 40 million people worldwide. CSU patients have been reported to show elevatedC5a levels, a major activator of mast cells and basophils which are thought to be significant contributors to CSU pathogenesis. In addition,studies suggest that complement activation (including C5a) in CSU can lead to histamine release. Current treatments are limited, and asignificant unmet need exists in a sizable proportion of patients.
INF904 for the treatment of HS
We are also pursuing development of INF904 forthe treatment of HS in a Phase 2a trial. HS is a chronic, recurrent, debilitating neutrophil-driven inflammatory disease that can persistfor years and tremendously impacts quality of life; it is characterized by abscesses, nodules and draining tunnels which can flare andcause scarring. INF904 inhibits the known C5a-induced effects on neutrophil activation and tissue accumulation of immune cells, includinggeneration of tissue damaging mechanisms (enzyme release and oxidative radical formation) as well as induction of NETosis – mechanismsthought to be involved in HS progression and draining tunnel formation. Clinical evidence with existing C5a/C5aR products also supportsthat blocking this pathway reduces lesion counts. Patients’ responses to treatment with approved anti-TNF-alpha or anti-IL17 drugsare known to wane over time in a significant number of cases; and treatment with new therapeutics acting through other molecular mechanismsare needed for these patients.
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Anti-C5a antibody IFX002
We are developing IFX002 for the treatment ofchronic inflammatory diseases. IFX002 is a highly potent anti- C5a antibody, which binds to the same domain of the C5a protein as vilobelimab,but which has a higher humanization grade and altered pharmacokinetic properties compared to vilobelimab. IFX002 is currently in preclinicaldevelopment. We consider IFX002 to be a life-cycle management product to vilobelimab, given the long remaining patent life of IFX002.
Development progress with anti-C5aantibody BDB-001 by collaborator Staidson BioPharmaceuticals
In July 2025, Staidson BioPharmaceuticals announcedthat data from a multicenter, randomized, open-label, placebo-controlled Phase 1/2 study met its primary efficacy endpoint, demonstratingthat anti-C5a therapy can reduce corticosteroid use and enable corticosteroid-free treatment in patients with AAV. The study also metits key secondary efficacy endpoint, showing that complete remission rates in the treatment arms were non-inferior to those in the placebogroup. We believe these findings highlight the potential of anti-C5a therapy to reduce corticosteroid dependency while maintaining effectivedisease control in this serious autoimmune condition. Based on the data, Staidson plans to advance BDB-001 into Phase 3 trials in AAV.
Financial highlights
As of June 30, 2025, we had available funds amountingto €53.7 million, composed of €13.0 million in cash and cash equivalents and €40.7 million in marketablesecurities. Of the €13.0 million cash and cash equivalents, €3.6 million are held in euros and €9.4 millionare held in U.S. dollars. Marketable securities held in U.S. dollars have a nominal value of $41.0 million (€35.0 million), marketablesecurities held in EUR have a nominal value of €6.0 million. We believe that our current funds on hand will be sufficient to fundour planned operations into 2027.
We anticipate that our expenses might increaseif and as we:
| ● | continue research, preclinical and clinical development efforts, as applicable, for any existing and future product candidates, includingvilobelimab, INF904 and IFX002; |
| ● | actively seek to identify additional research programs and additional product candidates; |
| ● | seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials, if any; |
| ● | establish and expand sales, marketing, distribution and other commercial infrastructure now and in the future to commercialize variousproducts for which we may obtain marketing authorization or approval, if any; |
| ● | require the scale-up and validation of the manufacturing process and the manufacturing of larger quantities of product candidatesfor clinical development and, potentially, commercialization; |
| ● | collaborate with strategic partners to optimize the manufacturing process for vilobelimab, IFX002, INF904 and other pipeline products; |
| ● | maintain, expand and protect our intellectual property portfolio; |
| ● | hire and retain additional personnel, such as commercial, marketing, clinical, quality control and scientific personnel; and |
| ● | add operational, financial and management information systems and personnel, including personnel to support our product developmentas well as commercialization and help us comply with our obligations as a public company. |
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Our ability to become and remain profitable dependson our ability to generate revenue. We do not expect to generate significant revenue unless and until we are, or any future collaboratoris, able to obtain full marketing authorization or approval for, and successfully commercialize, one or more of our product candidates.Successful commercialization will require achievement of key milestones, including completing clinical trials of vilobelimab, INF904 andany other product candidates, obtaining marketing authorization or approval for these product candidates, manufacturing, marketing andselling those products for which we, or any of our future collaborators, may obtain marketing authorization or approval, satisfying anypost-marketing requirements and obtaining reimbursement for our products from private insurance or government payors. Because of the uncertaintiesand risks associated with these activities, we are unable to accurately predict the timing and amount of revenues, and if or when we mightachieve profitability. We and any future collaborators may never succeed in these activities and, even if we do, or any future collaboratorsdo, we may never generate revenue that is large enough for us to achieve profitability. Even if we do achieve profitability, we may notbe able to sustain or increase profitability on a quarterly or annual basis.
We expect our financial condition and operatingresults to continue to fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control.In order to succeed, we will need to transition from a company with a research and development focus to a company capable of undertakingcommercial activities. We may encounter unforeseen expenses, difficulties, complications and delays, and may not be successful in sucha transition.
Accordingly, we may seek to further fund our operationsthrough public or private equity or debt financings or other sources, including strategic collaborations. We may, however, be unable toraise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital orenter into such other arrangements as and when needed would have a negative impact on our financial condition and our ability to developvilobelimab or any additional product candidates.
Our failure to become and remain profitable coulddepress the market price of our ordinary shares and could impair our ability to raise capital, pay dividends, expand our business, diversifyour product offerings or continue our operations. If we continue to suffer losses as we have in the past, investors may not receive anyreturn on their investment and may lose their entire investment.
Sales and marketing expenses
| ● | Sales and marketing expenses have consisted principally of: |
| ● | external services for distribution of GOHIBIC to build and maintain the necessary commercial and logistical infrastructure, includingexternal sales professionals; |
| ● | marketing activities; |
| ● | employee-related expenses, including salaries, benefits and stock-basedcompensation expense based upon employees’ role within the organization; and |
| ● | professional services fees in conjunction with making GOHIBIC available to hospitals and patients in the U.S. |
Research and development expenses
Research and development expenses have consistedprincipally of:
| ● | expenses incurred under agreements with CROs, contract manufacturing organizations, or CDMOs, consultants and independent contractorsthat 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 withinthe organization; and |
| ● | professional fees for lawyers related to the protection and maintenance of our intellectual property. |
We expense research and development costs as incurred.We recognize costs for certain development activities, such as preclinical studies and clinical trials, based on an evaluation of theprogress to completion of specific tasks. We use information provided to us by our vendors such as status of patient enrollment or clinicalsite activations for measuring services received and efforts expended. Research and development activities are central to our businessmodel.
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Our research and development expenses primarilyrelate to the following key programs:
| ● | Vilobelimab. We expect our expenses associated with vilobelimabwill decrease in 2025 compared to 2024, given the recent decision to stop our Phase 3 study in PG. However, we will still incur some costsassociated to our clinical activities, including the wind down of the Phase 3 trial in PG. |
| ● | INF904. We are developing INF904, a product candidate thattargets C5aR. We expect to incur additional costs by advancing the clinical and non-clinical development of INF904. Specifically, we expectto incur expenses by continuing our Phase 2a trial and potentially initiating larger Phase 2 clinical trials. We plan to study INF904in complement-mediated, chronic autoimmune and inflammatory conditions where an oral low molecular weight compound might have advantagesor is needed for patients and where oral delivery is the medically preferred route of administration. Initially targeted indications includeCSU and HS. |
| ● | IFX002. We are developing IFX002 for the treatment of chronicinflammatory indications. IFX002 is a highly potent anti-complement C5a antibody with a higher humanization grade and altered PK propertiescompared to vilobelimab and is currently in pre-clinical development. Expenses for this program mainly consist of salaries, costs forpreclinical testing conducted by CROs and costs to produce preclinical material. |
| ● | Other development programs. Our other research and developmentexpenses relate to our preclinical studies of other product candidates and discovery activities, expenses for which mainly consist ofsalaries, costs for production of preclinical compounds and costs paid to CROs. |
General and administrative expenses
Our general and administrative expenses consistprincipally of:
| ● | employee-related expenses, including salaries, benefits and stock-basedcompensation 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 filing, prosecution, protection and maintenance of our intellectual property; |
| ● | and insurance expenses including directors and officers liability insurance premiums, |
| ● | cost of facilities, travel, communication and office expenses. |
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Results of operations
The information below was derived from our unauditedinterim condensed consolidated financial statements included elsewhere herein. The discussion below should be read along with these unauditedinterim condensed consolidated financial statements and our Annual Report.
Comparison of the three monthsended June 30, 2025 and 2024
| three months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Revenues | 39,432 | 6,357 | 33,075 | |||||||||
| Cost of sales | (2,399,583 | ) | (348,153 | ) | (2,051,429 | ) | ||||||
| Gross profit | (2,360,151 | ) | (341,796 | ) | (2,018,354 | ) | ||||||
| Operating expenses | ||||||||||||
| Sales and marketing expenses | (1,013,347 | ) | (1,828,628 | ) | 815,280 | |||||||
| Research and development expenses | (7,202,942 | ) | (10,016,870 | ) | 2,813,928 | |||||||
| General and administrative expenses | (3,279,485 | ) | (3,226,098 | ) | (53,387 | ) | ||||||
| Total operating expenses | (11,495,775 | ) | (15,071,596 | ) | 3,575,821 | |||||||
| Other income | 937,938 | 16,730 | 921,208 | |||||||||
| Other expenses | — | — | — | |||||||||
| Operating result | (12,917,988 | ) | (15,396,663 | ) | 2,478,675 | |||||||
| Finance income | 522,221 | 848,243 | (326,022 | ) | ||||||||
| Finance expenses | (3,355 | ) | (8,732 | ) | 5,377 | |||||||
| Foreign exchange result | (2,869,983 | ) | 711,411 | (3,581,394 | ) | |||||||
| Other financial result | 852,834 | — | 852,834 | |||||||||
| Income taxes | — | — | — | |||||||||
| Income (loss) for the period | (14,416,271 | ) | (13,845,741 | ) | (570,531 | ) | ||||||
| Exchange differences on translation of foreign currency | (113,604 | ) | 28,374 | (141,978 | ) | |||||||
| Total comprehensive income (loss) | (14,529,876 | ) | (13,817,367 | ) | (712,509 | ) | ||||||
Revenues
| three months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Revenues | 39,432 | 6,357 | 33,075 | |||||||||
| Total | 39,432 | 6,357 | 33,075 | |||||||||
For the three months ended June 30, 2025, werealized €39 thousand revenues from product sales of GOHIBIC (vilobelimab) compared to revenues in the amount of €6 thousandfrom product sales of GOHIBIC (vilobelimab) in the three months ended June 30, 2024.
Revenues reported are sales to end customers(hospitals). Sales to distributors do not constitute revenue for the Company under IFRS 15. All revenues are attributed to sales madein the United States.
Cost of sales
| three months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Cost of sales | 2,399,583 | 348,153 | 2,051,429 | |||||||||
| Total | 2,399,583 | 348,153 | 2,051,429 | |||||||||
Cost of sales during the three months ended June30, 2025 increased by €2.1 million to €2.4 million, primarily due to higher inventory write-downs of €2.4 million. Write-downswere mainly to quantities of unfinished goods on-hand exceeding quantities expected to be sold prior to expiry and were determined bya multiple scenario analysis.
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Sales and marketing expenses
| three months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Third-party expenses | 13,132 | 898,423 | (885,291 | ) | ||||||||
| Marketing expenses | 463,187 | 409,309 | 53,878 | |||||||||
| Personnel expenses | 382,451 | 331,671 | 50,780 | |||||||||
| Legal and consulting fees | 105,602 | 171,281 | (65,679 | ) | ||||||||
| Other expenses | 48,976 | 17,944 | 31,032 | |||||||||
| Total sales and marketing expenses | 1,013,347 | 1,828,628 | (815,281 | ) | ||||||||
Our sales and marketing expenses incurred forthe three months ended June 30, 2025 decreased compared to the three months ended June 30, 2024 by €0.8 million to €1.0 million.This decrease is primarily due to lower cost in external services for distribution, mainly attributable to the in-sourcing of our salesstaff which has previously been provided through a third party.
Research and development expenses
| three months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Third-party expenses | 4,396,815 | 6,683,117 | (2,286,302 | ) | ||||||||
| thereof vilobelimab | 875,503 | 3,478,989 | (2,603,486 | ) | ||||||||
| thereof INF904 | 3,452,004 | 3,055,852 | 396,152 | |||||||||
| thereof non-allocated | 69,308 | 148,276 | (78,968 | ) | ||||||||
| Personnel expenses | 2,292,612 | 2,206,450 | 86,162 | |||||||||
| Other expenses | 513,515 | 1,127,303 | (613,788 | ) | ||||||||
| thereof vilobelimab | 201,581 | 728,839 | (527,258 | ) | ||||||||
| thereof INF904 | 66,657 | 6,915 | 59,742 | |||||||||
| thereof non-allocated | 245,277 | 391,549 | (146,272 | ) | ||||||||
| Total research and development expenses | 7,202,942 | 10,016,870 | (2,813,928 | ) | ||||||||
Our research and development expenses incurredfor the three months ended June 30, 2025 decreased by €2.8 million to €7.2 million compared to the three months endedJune 30, 2024. This decrease is primarily due to lower third-party expenses for clinical material and related manufacturing expenses.
General and administrative expenses
| three months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Personnel expenses | 1,657,678 | 1,696,730 | (39,053 | ) | ||||||||
| Legal, consulting and audit fees | 811,167 | 700,831 | 110,336 | |||||||||
| Other expenses | 810,641 | 828,537 | (17,897 | ) | ||||||||
| Total comprehensive income (Loss) | 3,279,485 | 3,226,098 | 53,387 | |||||||||
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Other income
| three months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Other income from government grants and research allowances | 919,150 | — | 919,150 | |||||||||
| Further other income | 18,788 | 16,730 | 2,058 | |||||||||
| Total other income | 937,938 | 16,730 | 921,208 | |||||||||
Our other income for the three months ended June30, 2025 increased by €0.9 million compared to the three months ended June 30,2024 and primarily consists of research allowancesunder the “Forschungszulagengesetz” (Research Allowance Act) for the three months ended June 30, 2024, which we did not receivein the three months ended June 30, 2024.
Net financial result
| three months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Interest income | 522,221 | 848,243 | (326,022 | ) | ||||||||
| Interest expenses | (323 | ) | (2,056 | ) | 1,733 | |||||||
| Interest on lease liabilities | (3,032 | ) | (6,676 | ) | 3,644 | |||||||
| Financial Result | 518,866 | 839,511 | (320,645 | ) | ||||||||
| Foreign exchange income | 1,892,850 | 1,754,243 | 138,607 | |||||||||
| Foreign exchange expense | (4,762,833 | ) | (1,042,832 | ) | (3,720,001 | ) | ||||||
| Foreign exchange result | (2,869,983 | ) | 711,411 | (3,581,394 | ) | |||||||
| Result from the revaluation of pre-funded warrants at fair value | 852,834 | — | 852,834 | |||||||||
| Other financial result | 852,834 | — | 852,834 | |||||||||
| Net financial result | (1,498,284 | ) | 1,550,922 | (3,049,205 | ) | |||||||
For the three months ended June 30, 2025, netfinancial result decreased by €3.0 million to a loss of €1.5 million from a gain of €1.6 million for thethree months ended June 30, 2024. This decrease is mainly attributable to the foreign exchange result which decreased by €3.6 million.Foreign currency losses amounted to €2.9 million, of which €2.4 million resulted from the valuation of our U.S. dollar denominatedsecurities holdings as of the reporting date. Financial result decreased by €0.3 million due to lower interest income on marketablesecurities, in each case, compared to the three months ended June 30,2024. Both effects are compensated by the fair value revaluationof pre-funded warrants issued in February 2025 in the amount of €0.9 million.
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| 18. | Comparison of the six months ended June30, 2025 and 2024 |
| six months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Revenues | 39,432 | 42,394 | (2,962 | ) | ||||||||
| Cost of sales | (2,408,874 | ) | (568,674 | ) | (1,840,200 | ) | ||||||
| Gross profit | (2,369,442 | ) | (526,280 | ) | (1,843,162 | ) | ||||||
| Operating expenses | ||||||||||||
| Sales and marketing expenses | (2,471,326 | ) | (3,288,167 | ) | 816,841 | |||||||
| Research and development expenses | (14,219,279 | ) | (17,318,680 | ) | 3,099,401 | |||||||
| General and administrative expenses | (8,342,090 | ) | (6,805,249 | ) | (1,536,841 | ) | ||||||
| Total operating expenses | (25,032,694 | ) | (27,412,095 | ) | 2,379,401 | |||||||
| Other income | 1,479,035 | 53,023 | 1,426,012 | |||||||||
| Other expenses | (26 | ) | — | (26 | ) | |||||||
| Operating result | (25,923,127 | ) | (27,885,353 | ) | 1,962,226 | |||||||
| Finance income | 1,015,985 | 1,754,148 | (738,163 | ) | ||||||||
| Finance expenses | (7,441 | ) | (10,844 | ) | 3,403 | |||||||
| Foreign exchange result | (4,778,812 | ) | 2,535,787 | (7,314,599 | ) | |||||||
| Other financial result | 6,963,097 | 103,285 | 6,859,812 | |||||||||
| Income taxes | — | — | — | |||||||||
| Income (loss) for the period | (22,730,298 | ) | (23,502,977 | ) | 772,678 | |||||||
| Exchange differences on translation of foreign currency | (264,271 | ) | 2,836 | (267,107 | ) | |||||||
| Total comprehensive income (loss) | (22,994,569 | ) | (23,500,141 | ) | 505,571 | |||||||
Revenues
| six months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Revenues | 39,432 | 42,394 | (2,962 | ) | ||||||||
| Total | 39,432 | 42,394 | (2,962 | ) | ||||||||
For the six months ended June 30, 2025, we realized€39 thousand revenues from product sales of GOHIBIC (vilobelimab) compared to revenues in the amount of €42 thousandfrom product sales of GOHIBIC (vilobelimab) in the six months ended June 30, 2024.
Revenues reported are sales to end customers(hospitals). Sales to distributors do not constitute revenue for the Company under IFRS 15. All revenues are attributed to sales madein the United States
Cost of sales
| six months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Cost of sales | 2,408,874 | 568,674 | 1,840,199 | |||||||||
| Total | 2,408,874 | 568,674 | 1,840,199 | |||||||||
Our cost of sales during the six months endedJune 30, 2025 amounted to €2.4 million primarily due to higher inventory write-downs of €2.4 million. Write-downs weremainly due to quantities of unfinished goods on-hand exceeding quantities expected to be sold prior to expiry and were determined by amultiple scenario analysis. In the same period in 2024 write downs were lower due to a longer shelf-life of inventory as of June 30, 2024.
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Sales and marketing expenses
| six months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Third-party expenses | 220,943 | 1,608,186 | (1,387,243 | ) | ||||||||
| Marketing expenses | 668,265 | 494,112 | 174,153 | |||||||||
| Personnel expenses | 1,026,667 | 655,244 | 371,423 | |||||||||
| Legal and consulting fees | 366,934 | 486,524 | (119,591 | ) | ||||||||
| Other expenses | 188,517 | 44,100 | 144,417 | |||||||||
| Total sales and marketing expenses | 2,471,326 | 3,288,167 | (816,841 | ) | ||||||||
Our sales and marketing expenses incurred forthe six months ended June 30, 2025 decreased by €0.8 million compared to the six months ended June 30, 2024 to €2.5 million.This decrease is primarily due to lower third party expenses mainly attributable to the in-sourcing of our sales staff which has previouslybeen provided through a third party and offset by higher personnel expenses.
Research and development expenses
| six months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Third-party expenses | 8,365,860 | 10,875,980 | (2,510,121 | ) | ||||||||
| thereof vilobelimab | 2,435,412 | 6,442,169 | (4,006,757 | ) | ||||||||
| thereof INF904 | 5,792,569 | 4,257,183 | 1,535,386 | |||||||||
| thereof non-allocated | 137,879 | 176,628 | (38,749 | ) | ||||||||
| Personnel expenses | 4,971,270 | 4,653,070 | 318,200 | |||||||||
| Other expenses | 882,149 | 1,789,629 | (907,481 | ) | ||||||||
| thereof vilobelimab | 321,770 | 881,381 | (559,611 | ) | ||||||||
| thereof INF904 | 113,024 | 106,950 | 6,074 | |||||||||
| thereof non-allocated | 447,355 | 801,298 | (353,943 | ) | ||||||||
| Total research and development expenses | 14,219,279 | 17,318,680 | (3,099,401 | ) | ||||||||
Our research and development expenses incurredfor the six months ended June 30, 2025 decreased by €3.1 million to €14.2 million compared to the six months endedJune 30, 2024. This decrease is primarily due to lower third-party expenses for clinical material and related manufacturing expenses.
General and administrative expenses
| six months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Personnel expenses | 4,286,388 | 3,717,105 | 569,283 | |||||||||
| Legal, consulting and audit fees | 2,420,129 | 1,270,956 | 1,149,172 | |||||||||
| Other expenses | 1,635,573 | 1,817,187 | (181,614 | ) | ||||||||
| Total comprehensive income (Loss) | 8,342,090 | 6,805,249 | 1,536,841 | |||||||||
Our general and administrative expenses incurredfor the six months ended June 30, 2025 increased by €1.5 million to €8.3 million, compared to the six months ended June30, 2024, mainly due to higher legal, consulting and audit expenses of €2.4 million and higher personnel expenses in the amountof €4.3 million.
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Other income
| six months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Other income from government grants and research allowances | 1,452,010 | — | 1,452,010 | |||||||||
| Further other income | 27,026 | 53,023 | (25,997 | ) | ||||||||
| Total other income | 1,479,035 | 53,023 | 1,426,012 | |||||||||
Our other income for the six months ended June30, 2025 increased by €1.4 million compared to the six months ended June 30, 2024. Our other income primarily consists of researchallowances under the “Forschungszulagengesetz” (Research Allowance Act) in the six months ended June 30, 2025, which we didnot receive in the six months ended June 30, 2024.
Net financial result
| six months ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| (in €) | ||||||||||||
| Interest income | 1,015,985 | 1,754,148 | (738,163 | ) | ||||||||
| Interest expenses | (766 | ) | 25 | (791 | ) | |||||||
| Interest on lease liabilities | (6,675 | ) | (10,869 | ) | 4,194 | |||||||
| Financial Result | 1,008,544 | 1,743,304 | (734,760 | ) | ||||||||
| Foreign exchange income | 3,121,858 | 3,803,826 | (681,967 | ) | ||||||||
| Foreign exchange expense | (7,900,671 | ) | (1,268,039 | ) | (6,632,632 | ) | ||||||
| Foreign exchange result | (4,778,812 | ) | 2,535,787 | (7,314,599 | ) | |||||||
| Result of expected credit loss adjustment on marketable securities | — | 103,285 | (103,285 | ) | ||||||||
| Result from the revaluation of pre-funded warrants at fair value | 6,963,097 | — | 6,963,097 | |||||||||
| Other financial result | 6,963,097 | 103,285 | 6,859,812 | |||||||||
| Net financial result | 3,192,828 | 4,382,376 | (1,189,548 | ) | ||||||||
For the six months ended June 30, 2025, net financialresult decreased by €1.2 million to a gain of €3.2 million in the six months ended June 30, 2025 from a gain of €4.4 millionin the six months ended June 30, 2024. This decrease is mainly attributable to the decrease of the foreign exchange result by €7.3 million.Foreign currency losses amounted to €4.8 million, of which €3.6 million resulted from the valuation of our U.S. dollar denominatedsecurities holdings as of the reporting date. Finance result decreased by €0.7 million due to lower interest income on marketablesecurities. Both effects are partially compensated by a gain of €7.0 million from the fair value revaluation of pre-funded warrants,issued in February 2025.
Liquidity and capital resources
Since inception, we have incurred significantoperating losses. For the six months ended June 30, 2025, we incurred a net loss of €22.7 million. To date, we have financedour operations primarily through the sale of our securities. As of June 30, 2025, we had cash and cash equivalents in the amount of €13.0 millionand financial assets in the amount of €40.9 million, comprised of marketable securities in the amount of €40.7 millionand other financial assets amounting to €0.2 million. Our cash and cash equivalents primarily consist of bank deposit accountsand fixed U.S. dollar term deposits.
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Cash flows
The table below summarizes our consolidated statementof cash flows for the six months ended June 30, 2025 and 2024:
| six months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| (in €) | ||||||||
| Net cash used in operating activities | (21,568,767 | ) | (27,002,634 | ) | ||||
| Net cash from/ (used in) investing activities | (7,250,803 | ) | 32,938,758 | |||||
| Net cash from/ (used in) financing activities | 26,909,693 | (193,053 | ) | |||||
| Cash and cash equivalents at the beginning of the period | 18,375,979 | 12,767,943 | ||||||
| Effect of Exchange gains/ (losses) on cash and cash equivalents | (3,462,651 | ) | 641,107 | |||||
| Cash and cash equivalents at the end of the period | 13,003,451 | 19,152,121 | ||||||
1. Netcash from/used in operating activities
The use of cash in all periods resulted primarilyfrom our net losses, adjusted for non-cash charges and changes in components of working capital. Net cash used in operating activitiesdecreased to €21.6 million in the six months ended June 30, 2025, from €27.0 million in the six months ended June30, 2024.
2. Netcash from/used in investing activities
Net cash from investing activities decreasedby €40.2 million in the six months ended June 30, 2025, mainly due to lower proceeds from maturity of marketable securitiesin the six months ended June 30, 2025 compared to the six months ended June 30, 2024. These proceeds were reinvested into interest bearingbank deposits, which are accounted for as part of cash and cash equivalents.
3. Netcash from/used in financing activities
Net cash from financing activities increasedby €27.1 million in the six months ended June 30, 2025, compared to the six months ended June 30, 2024, due to a public offeringof ordinary shares and pre-funded warrants in the six months ended June 30, 2025.
Funding requirements
We expect our expenses associated with vilobelimabto decrease in 2025 compared to 2024, given the recent decision to stop our Phase 3 study in PG. However, we will still incur some costsassociated to our clinical activities, including the wind down of the Phase 3 trial in PG. Furthermore, we will incur expenses, as wecontinue discussions with the FDA related to the planned submission of a BLA for full approval of GOHIBIC (vilobelimab) to treat severeCOVID-19 and potentially additional related indications, continue to pursue commercializing of GOHIBIC (vilobelimab) under the EUA foremergency use as granted by the FDA. Lastly, we also incur expenses related to the manufacturing of clinical trial materials and in connectionwith further optimizing our manufacturing process for vilobelimab in compliance with regulatory standards. Furthermore, we also have establishedcommercial scale production options and have initiated manufacturing campaigns to be able to serve the market needs in the United Statesunder the granted EUA.
We are advancing the development of INF904 throughthe ongoing Phase 2 clinical study. In parallel, we are also continuing with non-clinical development activities in relation to the manufacturingand additional non-clinical animal studies in order to prepare for this future development.
If clinical data is supportive, we may seek marketingapproval for any product candidates that we successfully develop. Additionally, we will validate and further develop the manufacturingprocess of our products to be able to apply for marketing authorization and to be able to provide a commercial-grade product. If we obtainmarketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to establishingsales, marketing, distribution, and other commercial infrastructure to commercialize such products. We will need to obtain substantialadditional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms,we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization efforts. We believethat our existing cash and cash equivalents and financial assets will enable us to fund our operating expenses and capital expenditurerequirements under our current business plan into 2027.
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Until such time, if ever, that we can generatesubstantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, royalty-basedfinancings, future collaborations, strategic alliances, licensing arrangements and revenues from product sales. To the extent that weraise additional capital through the sale of equity or convertible debt securities, the interest of our current shareholders will be diluted,and the terms of these securities may include voting or other rights that adversely affect your rights as an ordinary shareholder. Debtfinancing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, suchas incurring additional debt, making capital expenditures, or declaring dividends. If we raise funds through additional collaborations,strategic alliances or licensing arrangements with third parties, we may have to relinquish rights to our technologies, future revenuestreams, research programs or product candidates, or grant licenses on terms that may not be favorable to us.
At-the-market program
On June 28, 2024, we entered into a Sales Agreementwith Leerink Partners LLC, to sell our ordinary shares from time to time through an at-the-market, or ATM, equity offering program ofup to $75.0 million.
In the six months ended June 30, 2025, we issued145,420 ordinary shares under our ATM program, resulting in $353 thousand in net proceeds. Following this issuance under the ATM program,the remaining value authorized for sale under the ATM program is $73.5 million.
For more information as to the risks associatedwith our future funding needs, see “ITEM 3. Key Information––Risk factors” in our Annual Report.
Off-balance sheet arrangements
As of June 30, 2025, and during the periods presented,we did not have any off-balance sheet arrangements other as described under “ITEM 5. Operating and financial review and prospects—off-balancesheet arrangements” in our Annual Report.
Contractual obligations and commitments
We do not have any, and during the periods presentedwe did not have any, contractual obligations and commitments other than as described under “ITEM 5. Operating and Financial Reviewand Prospects—Liquidity and capital resources––Contractual obligations and commitments” in the Annual Report.
Quantitative and qualitative disclosures about market risk
During the six months ended June30, 2025, there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “ITEM11. Quantitative and Qualitative Disclosures About Market Risk” in the annual report
Critical judgments and accounting estimates
There have been no material changes to the significantaccounting policies and estimates described in “ITEM 5. Operating and Financial Review and Prospects—Critical judgments andaccounting estimates” in the annual report.
Critical accounting estimates
There have been no material changes to the significantaccounting policies and estimates described in Note B.2. to our consolidated financial statements in the annual report.
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Cautionary statement regarding forward looking statements
This discussion contains forward-looking statementsthat involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “may,”“will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,”“target,” “project,” “estimate,” “believe,” “predict,” “potential”or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future.These statements speak only as of the date of this discussion and involve known and unknown risks, uncertainties and other important factorsthat may cause our actual results, performance or achievements to be materially different from any future results, performance or achievementsexpressed or implied by the forward-looking statements. We based these forward-looking statements largely on our current expectationsand projections about future events and financial trends that we believe may affect our business, financial condition and results of operations.These forward-looking statements include, without limitation, statements about the following:
| ● | our ability to successfully secure distribution channels and commercialize GOHIBIC (vilobelimab) as a treatment for COVID-19 patientsand the receptiveness of our ability to positively influence treatment recommendations by U.S. and European hospitals, guideline bodiesand other third-party organizations; |
| ● | our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimatedreturns and return accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indication or for vilobelimaband any other product candidates, under the EUA, and in the future if approved for commercial use in the United States, Europe or elsewhere; |
| ● | our ability to successfully implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’streatment of other debilitating or life-threatening inflammatory indications, including ARDS and other indications, and any other productcandidates, including INF904, and whether such clinical results will reflect results seen in previously conducted pre-clinical studiesand clinical trials; |
| ● | the timing, progress and results of preclinical studies and clinical trials of vilobelimab, INF904 and any other product candidates,including for the development of vilobelimab in several indications, including to obtain full approval of GOHIBIC (vilobelimab) for COVID-19and other virally induced ARDS, to treat HS and CSU and statements regarding the timing of initiation and completion of studies or trialsand related preparatory work, the period during which the results of the trials will become available, the costs of such trials and ourresearch and development programs generally; |
| ● | our interactions with and the receptiveness and approval by regulators regarding the results of clinical trials and potential regulatoryapproval or authorization pathways, including our BLA submission for GOHIBIC (vilobelimab); |
| ● | the timing and outcome of any discussions or submission of filings for regulatory approval or authorization of vilobelimab, INF904or any other product candidate, and the timing of and our ability to obtain and maintain full regulatory approval, the EUA and/or marketauthorization of vilobelimab or GOHIBIC (vilobelimab) for any indication; |
| ● | our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediatedautoimmune and inflammatory diseases; |
| ● | our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, INF904 and any other product candidates,and the scope of such protection; |
| ● | whether the FDA, EMA or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct orimplementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; |
| ● | the success of our future clinical trials for vilobelimab, INF904 and any other product candidates and whether such clinical resultswill reflect results seen in previously conducted preclinical studies and clinical trials; |
| ● | our expectations regarding the size of the patient populations for, the market opportunity for, the medical need for and clinicalutility of vilobelimab, INF904 or any other product candidates, if approved or authorized for commercial use; |
| ● | our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and theoptimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturersand our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimaband for the finished product GOHIBIC (vilobelimab) in the U.S. and Europe; |
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| ● | our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additionalfinancing; |
| ● | our expectations regarding the scope of any approved indication for vilobelimab; |
| ● | our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if, approvedor authorized, any commercial sales; |
| ● | if any of our product candidates obtain regulatory approval or authorization, our ability to comply with and satisfy ongoing drugregulatory obligations and continued regulatory overview; |
| ● | our ability to comply with enacted and future legislation in seeking marketing approval or authorization 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 relatingto our competitors in the development of C5a and C5aR inhibitors and other therapeutic products being developed in similar medical conditionsin which vilobelimab, INF904 or any other of our product candidates is being developed or our industry; and |
| ● | other risk factors discussed under the “ITEM 3. Key information––Risk factors” section of our Annual Reporton Form 20-F. |
Because forward-looking statements are inherentlysubject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you shouldnot rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-lookingstatements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.You should refer to the “ITEM 3. Key information––Risk factors” section of our Annual Report and risks describedin our subsequent SEC filings for a discussion of important factors that may cause our actual results to differ materially from thoseexpressed or implied by our forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertaintiesmay emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of thesefactors, we cannot assure you that the forward-looking statements in this discussion or in our Annual Report will prove to be accurate.Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whetheras a result of any new information, future events, changed circumstances or otherwise. You should, however, review the factors and risksand other information we describe in the reports we will file from time to time with the SEC after the date of this discussion.
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Exhibit 99.3
InflaRx Reports Second Quarter 2025 FinancialResults and
Provides Business Update
| ● | INF904 Phase 2a data in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected bythe end of September to early November 2025 |
| ● | Phase 1/2 data announced by Staidson BioPharmaceuticals for InflaRx-partnered C5a antibody BDB-001 in ANCA-associatedvasculitis (AAV) were favorable, with Staidson expecting Phase 3 study initiation |
| ● | InflaRx working diligently toward unblinding of stopped Phase 3 pyoderma gangrenosum (PG) trial so that alldata can be analyzed later this year |
| ● | Enrollment began in BARDA funded JUST BREATHE Phase 2 platform clinical trial investigating vilobelimab andadditional novel therapeutic candidates for acute respiratory distress syndrome (ARDS) |
| ● | Cash, cash equivalents and marketable securities totaled €53.7 million on June 30, 2025 |
| ● | InflaRx estimates it has sufficient funds for currently planned operations into 2027, with review ongoingto determine feasibility of prioritizing additional resources toward INF904 |
Jena, Germany, August 7, 2025 –InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system,today announced its financial results for the three months ended June 30, 2025, and provided a business update.
Prof. Niels C. Riedemann, Chief ExecutiveOfficer and Founder of InflaRx, commented: “With the development of INF904, an oral C5aR inhibitor with best-in-class potential,InflaRx remains committed to targeting unmet needs in inflammatory disease and bringing new hope to patients. Data informing the clinicalutility of INF904 in chronic spontaneous urticaria and hidradenitis suppurativa are anticipated in the fall, potentially unlocking significantvalue in this pipeline program and driving INF904 one step further as an effective and safe oral option for patients with these painfuland debilitating skin conditions.”
Select recent highlights and business update
INF904 Phase 2a trial – Data expectedto provide significant clarity on clinical utility in CSU and HS
Given anticipated summer enrollment trends, we expectto report topline results from the ongoing Phase 2a basket study in HS and CSU by the end of September to early November. The data willinclude primary endpoints of pharmacokinetics (PK) and safety and also will include key clinical benefit endpoints after 4 weeks of treatment.InflaRx believes these data will provide clarity on the clinical utility of INF904 in both CSU and HS and will significantly inform thepotential paths forward for continued development.
Data released will include all three HS dosing cohorts(60 mg, 90 mg and 120 mg BID), as well as the two main CSU dosing cohorts (all-comers dosed with either 60 mg or 120 mg BID) containingboth anti-IgE naïve and anti-IgE experienced patients. Enrollment in a third CSU dosing cohort (120 mg) targeting Type IIb phenotypepatients very stringently selected as highly refractory to anti-IgE therapy is ongoing. The inclusion criteria for this third CSU armhave recently been broadened. Data from this last cohort in CSU will be announced in due course and, given sufficient demonstrated potentialin the all-comer arms, is not expected to impact the timing of CSU Phase 2b trial initiation.
The Phase 2a trial is a multi-center, open-labelstudy evaluating multiple INF904 dosing regimens over 4 weeks of treatment in a total of 75 patients (45 with CSU and 30 with HS). Thegoal of the trial is to generate additional safety and PK data and to demonstrate signs of clinical benefit, with the additional objectiveof informing Phase 2b trial go/no go decisions and study planning by year-end 2025.
InflaRx believes CSU and HS may each represent addressablemarkets of $1 billion or more for INF904. While the Company intends to focus its resources on its immediate goals in these two indications,it continues to assess the value of pursuing additional applications in inflammation via potential future collaborations with partners.
GOHIBIC (vilobelimab) for ARDS
In June 2025, BARDA announced enrollment of the firstpatient in the JUST BREATHE Phase 2 platform clinical trial investigating novel therapeutic candidates for ARDS. The clinical trial isbeing implemented by the PPD clinical research business of Thermo Fisher Scientific and aims to evaluate the safety and efficacy of threehost-directed therapeutic candidates at up to 60 U.S. sites, targeting a total enrollment of 600 hospitalized adult patients with ARDS.
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Vilobelimab for pyoderma gangrenosum (PG)
In May 2025, InflaRxannounced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for vilobelimabin PG recommended that the trial be stopped due to futility. This action was based on analysis of the first 30 patients enrolled in thestudy, with no unexpected adverse events noted by the IDMC. The Phase 3 PG study has been closed, and InflaRx is working diligently towardsdatabase lock so that all data can be analyzed and unblinded later this year. In addition, the Company continues to carefully assess theopportunity to reallocate resources from PG activities toward INF904 development.
Development progress with anti-C5a antibodyBDB-001 by collaborator Staidson BioPharmaceuticals
In July 2025, Staidson BioPharmaceuticals announcedthat a multicenter, randomized, open-label, placebo-controlled Phase 1/2 study met its primary efficacy endpoint, demonstrating that anti-C5atherapy can reduce corticosteroid use and enable corticosteroid-free treatment in patients with AAV. The study also met its key secondaryefficacy endpoint, showing that complete remission rates in the treatment arms were non-inferior to those in the placebo group. We believethese findings highlight the potential of anti-C5a therapy to reduce corticosteroid dependency while maintaining effective disease controlin this serious autoimmune condition. Based on the data, Staidson plans to advance BDB-001 into Phase 3 trials in AAV.
Under a co-development agreement in China, InflaRxgranted Staidson BioPharmaceuticals the right to use the vilobelimab cell line to develop and manufacture the anti-C5a antibody BDB-001.InflaRx is entitled to receive royalties on net sales of Staidson products containing BDB-001, including mid-single-digit percentage royaltieson future sales in AAV. Details of this collaboration agreement can be found in our latest 20-F filing.
Regarding the primary endpoint, week 12 partial remissionrate, based on the last observation carried forward (LOCF) analysis, the four treatment groups (low dose + steroid tapering, high dose+ steroid tapering, low dose without steroids, high dose without steroids) had comparable efficacy to the standard treatment group (standardsteroids). Partial remission rates at week 12 were 65.0%, 76.2%, 62.5%, 76.5%, vs. 68.4% (placebo), respectively.
Regarding the secondary endpoint, week 12 completeremission rate, also based on LOCF analysis, all experimental groups showed numerically higher complete remission rates than the standardtreatment group: 30.0%, 33.3%, 37.5%, 52.9%, vs. 5.3% (placebo), respectively.
Overall safety was positive, and risks were controllable.The incidence of Grade 3 or higher adverse events was 34.4%, with balanced distribution across groups (18.8%–41.2% in experimentalgroups vs. 47.4% in control group). The incidence of serious adverse events was 24.7%; the lowest was in the low dose without steroidgroup (6.3%), and the rest were comparable to control (19.0%–35.3% vs. 36.8%).
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GOHIBIC (vilobelimab) in the EU
GOHIBIC (vilobelimab) is approved in the EuropeanUnion (EU) under exceptional circumstances for the treatment of adults with SARS-CoV-2-induced ARDS who are receiving systemic corticosteroidsas part of standard of care and receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO).
GOHIBIC (vilobelimab) is the first and only treatmentapproved in the EU for the treatment of SARS-CoV-2-induced ARDS. InflaRx continues to pursue commercial partnering and distribution optionsin this geography and does not expect this approach will have a materially negative impact on its cash burn rate.
Dr. Thomas Taapken, Chief Financial Officerof InflaRx, said: “With our solid balance sheet, disciplined financial management, and a cashrunway into 2027, we remain well positioned for the upcoming data readouts for INF904 in CSU and HS.”
Financial highlights – 2Q 2025
Revenue
For the six months ended June 30, 2025, we realized€39 thousand in revenues from sales of GOHIBIC (vilobelimab). Compared to the six months ended June 30, 2024, this is a decreaseof €3 thousand. Sales to distributors do not constitute revenue for the Company. All revenues are attributed to sales in the UnitedStates.
Cost of sales
Cost of sales during the six months ended June 30,2025 amounted to €2.4 million, primarily due to higher inventory write-downs of €2.4 million. Write-downs were primarilyquantities of unfinished goods on hand exceeding quantities expected to be sold prior to expiry and were determined by a multiple-scenarioanalysis. In the same period in 2024, write-downs were lower due to a longer inventory shelf life as of June 30, 2024.
Sales and marketing expenses
Sales and marketing expenses incurred for the sixmonths ended June 30, 2025 decreased by €0.8 million compared to the six months ended June 30, 2024 to €2.5 million.This decrease is primarily due to lower third-party expenses mainly attributable to the in-sourcing of our sales staff which was previouslyprovided through a third party and offset by higher personnel expenses.
Research and development expenses
Research and development expenses incurred for thesix months ended June 30, 2025 decreased by €3.1 million to €14.2 million compared to the six months ended June 30,2024. This decrease is primarily due to lower third-party expenses for clinical material and related manufacturing expenses.
General and administrative expenses
General and administrative expenses incurred forthe six months ended June 30, 2025 increased by €1.5 million to €8.3 million, compared to the six months ended June 30,2024, mainly due to higher legal, consulting and audit expenses of €2.4 million and higher personnel expenses in the amountof €4.3 million.
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Other income
Other income for the six months ended June 30, 2025amounted to €1.5 million, compared to €53 thousand for the six months ended June 30, 2024. Other income was primarily due toother income from research allowances.
Net financial result
Net financial result decreased by €1.2 millionto a gain of €3.2 million for the six months ended June 30, 2025, from a gain of €4.4 million for the six months endedJune 30, 2024. This decrease was mainly attributable to the decrease of the foreign exchange result by €7.3 million. Foreigncurrency losses amounted to €4.8 million, of which €3.6 million resulted from the valuation of our U.S. dollar denominated securitiesholdings as of the reporting date. Finance result decreased by €0.7 million due to lower interest income on marketable securities.Both effects were partially offset by a gain of €7.0 million from the fair value revaluation of pre-funded warrants, issued in February2025.
Net loss
We incurred a net loss of €23.0 million, or€0.35 per ordinary share, during the six months ended June 30, 2025, compared to €23.5 million, or €0.40 per ordinary share,in 2024.
Liquidity and capital resources
As of June 30, 2025, our total funds available amountedto approximately €53.7 million, comprised of €13.0 million in cash and cash equivalents and €40.7 millionin marketable securities.
Net cash used in operating activities
Net cash used in operating activities decreased to€21.6 million in the six months ended June 30, 2025, from €27.0 million in the six months ended June 30, 2024.
Net cash from financing activities
Net cash from financing activities increased by €27.1 millionin the six months ended June 30, 2025, compared to the six months ended June 30, 2024, due to a public offering of ordinary shares andpre-funded warrants in the six months ended June 30, 2025.
Additional financial information
Additional information regarding these results andother relevant information is included in the notes to the financial statements in “Item 18. Financial Statements”, whichare included in InflaRx’s most recent annual report on Form 20-F as filed on March 20, 2025 with the U.S. Securities and ExchangeCommission.
5
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statementsof operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024
| For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 (unaudited) | 2024 (unaudited) | 2025 (unaudited) | 2024 (unaudited) | |||||||||||||
| (in €, except for share data) | ||||||||||||||||
| Revenues | 39,432 | 6,357 | 39,432 | 42,394 | ||||||||||||
| Cost of sales | (2,399,583 | ) | (348,153 | ) | (2,408,874 | ) | (568,674 | ) | ||||||||
| Gross profit (loss) | (2,360,151 | ) | (341,796 | ) | (2,369,442 | ) | (526,280 | ) | ||||||||
| Sales and marketing expenses | (1,013,347 | ) | (1,828,628 | ) | (2,471,326 | ) | (3,288,167 | ) | ||||||||
| Research and development expenses | (7,202,942 | ) | (10,016,870 | ) | (14,219,279 | ) | (17,318,680 | ) | ||||||||
| General and administrative expenses | (3,279,485 | ) | (3,226,098 | ) | (8,342,090 | ) | (6,805,249 | ) | ||||||||
| Other income | 937,938 | 16,730 | 1,479,035 | 53,023 | ||||||||||||
| Other expenses | — | — | (26 | ) | — | |||||||||||
| Operating result | (12,917,988 | ) | (15,396,663 | ) | (25,923,127 | ) | (27,885,353 | ) | ||||||||
| Finance income | 522,221 | 848,243 | 1,015,985 | 1,754,148 | ||||||||||||
| Finance expenses | (3,355 | ) | (8,732 | ) | (7,441 | ) | (10,844 | ) | ||||||||
| Foreign exchange result | (2,869,983 | ) | 711,411 | (4,778,812 | ) | 2,535,787 | ||||||||||
| Other financial result | 852,834 | — | 6,963,097 | 103,285 | ||||||||||||
| Income taxes | — | — | — | — | ||||||||||||
| Income (loss) for the period | (14,416,271 | ) | (13,845,741 | ) | (22,730,298 | ) | (23,502,977 | ) | ||||||||
| Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | ||||||||||||||||
| Exchange differences on translation of foreign currency | (113,604 | ) | 28,374 | (264,271 | ) | 2,836 | ||||||||||
| Total comprehensive income (loss) | (14,529,876 | ) | (13,817,367 | ) | (22,994,569 | ) | (23,500,141 | ) | ||||||||
| Share information | ||||||||||||||||
| Weighted average number of shares outstanding | 67,747,130 | 58,883,272 | 65,542,269 | 58,883,272 | ||||||||||||
| Income (loss) per share (basic/diluted) | (0.21 | ) | (0.24 | ) | (0.35 | ) | (0.40 | ) | ||||||||
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InflaRx N.V.and subsidiaries
Unaudited condensed consolidated statementsof financial position as of June 30, 2025 and December 31, 2024
| June 30, 2025 (unaudited) | December 31, 2024 | |||||||
| (in €) | ||||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Property and equipment | 247,027 | 256,280 | ||||||
| Right-of-use assets | 559,286 | 758,368 | ||||||
| Intangible assets | 50,106 | 50,781 | ||||||
| Other assets | 177,716 | 204,233 | ||||||
| Financial assets | 6,235,346 | 3,092,290 | ||||||
| Total non-current assets | 7,269,480 | 4,361,952 | ||||||
| Current assets | ||||||||
| Inventories | 5,038,415 | 6,897,666 | ||||||
| Current other assets | 5,519,954 | 5,103,402 | ||||||
| Other assets from government grants and research allowance | 5,863,947 | 5,081,772 | ||||||
| Tax receivables | 1,753,638 | 1,735,335 | ||||||
| Financial assets | 34,993,289 | 34,462,352 | ||||||
| Cash and cash equivalents | 13,003,450 | 18,375,979 | ||||||
| Total current assets | 66,172,692 | 71,656,505 | ||||||
| TOTAL ASSETS | 73,442,172 | 76,018,457 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Equity | ||||||||
| Issued capital | 8,129,656 | 7,122,205 | ||||||
| Share premium | 348,956,615 | 334,929,685 | ||||||
| Other capital reserves | 47,704,375 | 44,115,861 | ||||||
| Accumulated deficit | (354,922,519 | ) | (332,192,221 | ) | ||||
| Other components of equity | 7,176,239 | 7,440,510 | ||||||
| Total equity | 57,044,365 | 61,416,039 | ||||||
| Non-current liabilities | ||||||||
| Lease liabilities | 203,878 | 399,066 | ||||||
| Other liabilities | 36,877 | 36,877 | ||||||
| Total non-current liabilities | 240,755 | 435,943 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 9,735,656 | 11,394,232 | ||||||
| Lease liabilities | 395,234 | 406,020 | ||||||
| Employee benefits | 1,114,635 | 2,064,678 | ||||||
| Liabilities to warrant holders | 4,549,915 | — | ||||||
| Other liabilities | 361,613 | 301,544 | ||||||
| Total current liabilities | 16,157,053 | 14,166,475 | ||||||
| Total liabilities | 16,397,808 | 14,602,417 | ||||||
| TOTAL EQUITY AND LIABILITIES | 73,442,172 | 76,018,457 | ||||||
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InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statementsof changes in shareholders’ equity
for the six months ended June 30, 2025 and 2024
| (in €, except for share data) | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other compo- nents of equity | Total equity | ||||||||||||||||||
| Balance as of January 1, 2025 | 7,122,205 | 334,929,685 | 44,115,861 | (332,192,221 | ) | 7,440,510 | 61,416,039 | |||||||||||||||||
| Loss for the period | — | — | — | (22,730,298 | ) | — | (22,730,298 | ) | ||||||||||||||||
| Exchange differences on translation of foreign currency | — | — | — | — | (264,271 | ) | (264,271 | ) | ||||||||||||||||
| Total comprehensive loss | — | — | — | (22,730,298 | ) | (264,271 | ) | (22,994,569 | ) | |||||||||||||||
| Issuance of ordinary shares | 1,007,450 | 15,136,235 | — | — | — | 16,143,686 | ||||||||||||||||||
| Transaction costs for ordinary shares | — | (1,109,305 | ) | — | — | — | (1,109,305 | ) | ||||||||||||||||
| Equity-settled share-based payments | — | — | 3,588,514 | — | — | 3,588,514 | ||||||||||||||||||
| Balance as of June 30, 2025 | 8,129,656 | 348,956,615 | 47,704,375 | (354,922,519 | ) | 7,176,239 | 57,044,365 | |||||||||||||||||
| Balance as of January 1, 2024 | 7,065,993 | 334,211,338 | 40,050,053 | (286,127,819 | ) | 7,382,166 | 102,581,730 | |||||||||||||||||
| Loss for the period | — | — | — | (23,502,977 | ) | — | (23,502,977 | ) | ||||||||||||||||
| Exchange differences on translation of foreign currency | — | — | — | — | 2,836 | 2,836 | ||||||||||||||||||
| Total comprehensive loss | — | — | — | (23,502,977 | ) | 2,836 | (23,500,141 | ) | ||||||||||||||||
| Equity-settled share-based payments | — | — | 3,073,814 | — | — | 3,073,814 | ||||||||||||||||||
| Balance as of June 30, 2024 | 7,065,993 | 334,211,338 | 43,123,867 | (309,630,796 | ) | 7,385,002 | 82,155,403 | |||||||||||||||||
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InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statementsof cash flows
for the six months ended June 30, 2025 and 2024
| For the six months ended June 30, | ||||||||
| 2025 (unaudited) | 2024 (unaudited) | |||||||
| (in €) | ||||||||
| Operating activities | ||||||||
| Loss for the period | (22,730,298 | ) | (23,502,977 | ) | ||||
| Adjustments for: | ||||||||
| Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | 228,801 | 262,932 | ||||||
| Net finance income | (3,192,828 | ) | (4,382,376 | ) | ||||
| Share-based payment expense | 3,588,514 | 3,073,813 | ||||||
| Net foreign exchange differences and other adjustments | 1,518,421 | (101,055 | ) | |||||
| Changes in: | ||||||||
| Other assets from government grants and research allowances | (782,175 | ) | — | |||||
| Other assets and trade receivables | (408,339 | ) | 1,189,849 | |||||
| Employee benefits | (950,043 | ) | (484,102 | ) | ||||
| Other liabilities | 60,068 | (2,711,447 | ) | |||||
| Trade and other payables | (1,658,576 | ) | (3,429,460 | ) | ||||
| Inventories | 1,859,251 | 1,723,566 | ||||||
| Interest received | 906,087 | 1,369,670 | ||||||
| Interest paid | (7,652 | ) | (11,048 | ) | ||||
| Net cash used in operating activities | (21,568,767 | ) | (27,002,634 | ) | ||||
| Investing activities | ||||||||
| Purchase of intangible assets, property and equipment | (25,673 | ) | (28,310 | ) | ||||
| Purchase of current financial assets | (35,514,042 | ) | (23,254,210 | ) | ||||
| Proceeds from the maturity of financial assets | 28,288,912 | 56,221,278 | ||||||
| Net cash from / (used in) investing activities | (7,250,803 | ) | 32,938,758 | |||||
| Financing activities | ||||||||
| Proceeds from issuance of ordinary shares | 16,143,686 | — | ||||||
| Proceeds from pre-funded warrants | 12,915,909 | — | ||||||
| Transaction costs from issuance of ordinary shares and pre-funded warrants | (1,949,998 | ) | — | |||||
| Repayment of lease liabilities | (199,904 | ) | (193,053 | ) | ||||
| Net cash from / (used in) financing activities | 26,909,693 | (193,053 | ) | |||||
| Net increase in cash and cash equivalents | (1,909,878 | ) | 5,743,071 | |||||
| Effect of exchange rate changes on cash and cash equivalents | (3,462,651 | ) | 641,107 | |||||
| Cash and cash equivalents at beginning of period | 18,375,979 | 12,767,943 | ||||||
| Cash and cash equivalents at end of period | 13,003,450 | 19,152,121 | ||||||
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About GOHIBIC (vilobelimab)
In the United States, vilobelimab has been grantedan Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults wheninitiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) under the tradename GOHIBIC. The emergency use of GOHIBIC (vilobelimab) is only authorized for the duration of the declaration that circumstances existjustifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1)of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner. GOHIBIC (vilobelimab)is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19. There islimited information known about the safety and effectiveness of using GOHIBIC (vilobelimab) to treat people in the hospital with COVID-19.Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letterof Authorization on the GOHIBIC website http://www.gohibic.com.
In the European Union, GOHIBIC (vilobelimab) hasbeen granted marketing authorization (Marketing Authorization) under exceptional circumstances for the treatment of adult patients withSARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care andreceiving IMV with or without ECMO. The EU approval of GOHIBIC (vilobelimab) is supported by the previously announced results of the multicenterPhase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilatedCOVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in28-day all-cause mortality of 23.9% compared to placebo in the global data set. The data were published in The Lancet Respiratory Medicine.
A Marketing Authorization under exceptional circumstancesis recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikelythat comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC (vilobelimab)’s approval in theEuropean Commission, InflaRx will provide annual updates to European Medicines Agency on the previously announced clinical platform studyby the Biomedical Advanced Research and Development Authority. Vilobelimab is included in this study as one of three new potential therapiesfor treating ARDS.
The COVID-19 related work described herein was partlyfunded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lieswith InflaRx.
Important Safety Information about GOHIBIC(vilobelimab)
There is limited clinical data available for GOHIBIC(vilobelimab). Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC (vilobelimab)use.
GOHIBIC (vilobelimab) has been associated with anincrease of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatmentwith GOHIBIC (vilobelimab). Hypersensitivity reactions have been observed with GOHIBIC (vilobelimab). If a severe hypersensitivity reactionoccurs, administration of GOHIBIC (vilobelimab) should be discontinued and appropriate therapy initiated.
The most common adverse reactions (incidence ≥3%)are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection,bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratorytract infection, supraventricular tachycardia, constipation, and rash.
Healthcare providers and/or their designee are responsiblefor mandatory FDA MedWatch reporting of all medication errors, serious AEs or deaths that occur during GOHIBIC (vilobelimab) treatmentand are considered to be potentially attributable to GOHIBIC (vilobelimab).
Report side effects to the FDA at 1-800-FDA-1088or www.FDA.gov/medwatch. In addition, side effects can be reported to InflaRx at: pvusa@inflarx.de.
For the full prescribing information and additionalimportant safety information, please visit www.GOHIBIC.com.
About vilobelimab
Vilobelimab is a first-in-class monoclonal anti-humancomplement factor C5a antibody, which highly and effectively blocks the biological activity of free C5a and demonstrates high selectivitytowards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an importantdefense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab hasbeen shown to control the inflammatory response-driven tissue and organ damage by specifically blocking free C5a as a key “amplifier”of this response.
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About INF904
INF904 is an orally administered, small moleculeinhibitor of the C5a receptor Ca5R1 that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models. Further,in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has minimal inhibition of the cytochrome P4503A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids.Reported results from a first-in-human study demonstrated that INF904 is well tolerated in treated subjects and exhibits no safety signalsof concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of INF904 with a ≥90% blockade of C5a-induced neutrophilactivation achieved over the 14-day dosing period.
About InflaRx N.V.
InflaRx (Nasdaq: IFRX) is a biopharmaceutical companypioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercializehighly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediatorinvolved in the progression of a wide variety of inflammatory diseases. InflaRx has developed vilobelimab, a novel, intravenously delivered,first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activityand tolerability in multiple clinical studies. InflaRx is also developing INF904, an orally administered small molecule inhibitor of C5a-inducedsignaling via the C5a receptor.
InflaRx was founded in 2007, and the group has officesand subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRxGmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).
Contacts:
| InflaRx N.V. | MC Services AG | |
Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de | Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752 |
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements.All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,”“will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,”“target,” “project,” “estimate,” “believe,” “predict,” “potential”or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may includestatements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things,the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals and related treatment recommendationsby medical/healthcare institutes and other third-party organizations; our ability to successfully commercialize and the receptivenessof GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectationsregarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and returnaccruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indications or for vilobelimab and any otherproduct candidates, under an EUA and in the future if approved for commercial use in the U.S. or elsewhere; our ability to successfullyimplement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’s treatment of COVID-19 andother debilitating or life-threatening inflammatory indications, including PG, and any other product candidates, including INF904, andwhether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing,progress and results of pre-clinical studies and clinical trials of our product candidates and statements regarding the timing of initiationand 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; our interactions with regulators regarding the results ofclinical trials and potential regulatory approval pathways, including related to our biologics license application submission for GOHIBIC(vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication;whether the FDA, or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementationof our clinical trials, including any proposed primary or secondary endpoints for such trials; our expectations regarding the scope ofany approved indication for vilobelimab; our ability to leverage our proprietary anti-C5a and C5aR technologies to discover and developtherapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectualproperty protection for vilobelimab and any other product candidates, and the scope of such protection; our manufacturing capabilitiesand strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturingmethods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additionalthird-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished productGOHIBIC (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or abilityto obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates inthe clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply withand satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seekingmarketing approval and commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruitingadditional qualified personnel; and our competitive position and the development of and projections relating to our competitors in thedevelopment of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “RiskFactors” in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve knownand unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materiallydifferent from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks,uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligationto update these forward-looking statements, even if new information becomes available in the future, except as required by law.
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