InflaRx (IFRX) sets up $65 million at-the-market stock offering via Leerink
InflaRx N.V. is registering and may offer and sell, from time to time, ordinary shares with an aggregate offering price of up to $65,000,000 through Leerink Partners LLC in an at-the-market offering under an existing Form F-3 shelf. Sales may be made on Nasdaq or other permitted methods, with Leerink receiving up to 3.0% of gross proceeds as commission. Assuming sales at $2.01 per share, up to 32,338,308 ordinary shares would be outstanding after the offering, compared with 147,368,221 shares outstanding as of June 30, 2026. As of that date, net tangible book value was $165.6 million, or $1.12 per share; on a pro forma basis after a full $65 million sale it would be $228.5 million, or $1.27 per share, implying purchaser dilution of $0.74 per share at the assumed price. InflaRx reports under IFRS, focuses on anti-C5a/C5aR inflammatory therapies, and plans to use any net proceeds primarily for research and development of its clinical and preclinical programs, as well as working capital and general corporate purposes.
Positive
- None.
Negative
- None.
Filing Explained
The $65 million ATM capacity is effective, but no subsequent issuance or proceeds are reported; dilution remains conditional on future sales.
This filing makes the remaining
For existing common holders, the structural effect is conditional: if shares are sold and issued, the share count rises and each holder’s percentage ownership falls; the filing states that no ordinary shares were issued under the ATM after
As of
The filing says future quarterly reports will disclose shares sold through Leerink Partners, net proceeds and compensation, providing the stated path for determining whether this capacity becomes an issuance.
Key Figures
Key Terms
at the market offering financial
Baby Shelf Limitation regulatory
passive foreign investment company financial
qualified electing fund election financial
Subpart F income financial
Offering Details
FAQ
What is InflaRx (IFRX) offering in this 424B5 filing?
How many InflaRx (IFRX) shares could be outstanding after the ATM offering?
How will InflaRx (IFRX) use the proceeds from this offering?
What are InflaRx’s (IFRX) current liquidity levels and cash runway?
What dilution will new investors face in the InflaRx (IFRX) ATM offering?
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AI-generated analysis. How Rhea-AI works. Not financial advice.
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PRESENTATION OF FINANCIAL INFORMATION | S-ii | ||
TRADEMARKS | S-iii | ||
ABOUT THIS PROSPECTUS SUPPLEMENT | S-iv | ||
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS | S-v | ||
PROSPECTUS SUPPLEMENT SUMMARY | S-1 | ||
THE OFFERING | S-5 | ||
RISK FACTORS | S-6 | ||
USE OF PROCEEDS | S-9 | ||
DIVIDEND POLICY | S-10 | ||
DILUTION | S-11 | ||
MATERIAL DUTCH TAX CONSIDERATIONS | S-12 | ||
MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS | S-18 | ||
PLAN OF DISTRIBUTION | S-23 | ||
LEGAL MATTERS | S-25 | ||
EXPERTS | S-26 | ||
WHERE YOU CAN FIND MORE INFORMATION | S-27 | ||
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE | S-28 | ||
Page | |||
ABOUT THIS PROSPECTUS | 1 | ||
WHERE YOU CAN FIND MORE INFORMATION | 1 | ||
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS | 2 | ||
INFLARX N.V. | 4 | ||
RISK FACTORS | 8 | ||
USE OF PROCEEDS | 9 | ||
CAPITALIZATION | 10 | ||
DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION | 11 | ||
COMPARISON OF DUTCH CORPORATE LAW AND OUR ARTICLES OF ASSOCIATION AND U.S. CORPORATE LAW | 17 | ||
DESCRIPTION OF DEBT SECURITIES | 28 | ||
DESCRIPTION OF WARRANTS | 32 | ||
DESCRIPTION OF PURCHASE CONTRACTS | 33 | ||
DESCRIPTION OF UNITS | 34 | ||
FORMS OF SECURITIES | 35 | ||
PLAN OF DISTRIBUTION | 37 | ||
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE | 39 | ||
ENFORCEMENT OF CIVIL LIABILITIES | 40 | ||
EXPENSES | 42 | ||
LEGAL MATTERS | 43 | ||
EXPERTS | 43 | ||
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• | the success of our development and registrational strategy for izicopan’s treatment of ANCA-associated vasculitis, or AAV, and other renal diseases, including atypical hemolytic uremic syndrome, or aHUS, IgA nephropathy, or IgAN, and C3 glomerulopathy, or C3G, including our Phase 2 planning in AAV, our assessment of a broader development and registrational strategy in Europe following the recommendation by the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, to revoke the marketing authorization for Tavneos in the European Union, and our ability to establish proof-of-concept for izicopan across such indications; |
• | the success of our future clinical trials for vilobelimab’s treatment of debilitating or life-threatening inflammatory indications, including acute respiratory distress syndrome, or ARDS, and AAV; |
• | the potential strategic transactions or collaborations, including a potential partnership of izicopan or vilobelimab for pyoderma gangrenosum, or PG, HS, CSU or any other indications; |
• | the timing, progress and results of preclinical studies and clinical trials of vilobelimab, izicopan and any other product candidates, including for the development of vilobelimab or izicopan in several indications including virally induced ARDS, hidradenitis suppurativa, or HS, chronic spontaneous urticaria, or CSU, or others, and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; |
• | our interactions with and the receptiveness and approval by regulators regarding the results of clinical trials and potential regulatory approval or authorization pathways, including our intended engagement with the EMA regarding vilobelimab and izicopan; |
• | the timing and outcome of any discussions or submission of filings for regulatory approval of vilobelimab, izicopan or any other product candidate, if approved or authorized for commercial use; |
• | our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediated immunological and inflammatory diseases; |
• | our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of such protection; |
• | whether the U.S. Food and Drug Administration, or the FDA, the EMA or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; |
• | the success of our future clinical trials for vilobelimab, izicopan and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials; |
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• | our expectations regarding the size of the patient populations for, the market opportunity for, the medical need for and clinical utility of vilobelimab, izicopan 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 the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of any development candidate in the United States and Europe; |
• | our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; |
• | our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved or authorized, any commercial sales; |
• | if any of our product candidates obtain regulatory approval or authorization, our ability to comply with and satisfy ongoing drug regulatory obligations and continued regulatory oversight; |
• | 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 relating to our competitors in the development of C5a and C5aR inhibitors and other therapeutic products being developed in similar medical conditions in which vilobelimab, izicopan or any other of our product candidates is being developed or our industry; |
• | risks related to our reliance on foreign third-party manufacturers and suppliers, including those located in China; and |
• | other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. |
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• | Proceed with clinical development of izicopan in AAV and additional renal diseases. We have conducted a single ascending dose and multiple ascending dose study of our C5aR antagonist izicopan, and a Phase 2a trial in HS and CSU. We are also conducting required non-clinical studies. Our previously announced Phase 2 planning with izicopan in AAV continues as planned and uninterrupted across multiple geographies, and we are working to establish a rapid proof-of-concept for izicopan across additional renal disease targets, including aHUS, IgAN and C3G. |
• | Assess a broadened AAV strategy in Europe. Following the recommendation by the EMA’s Committee for Medicinal Products for Human Use to revoke the marketing authorization for Tavneos in the European Union, InflaRx is assessing the feasibility of broadening its development and registrational strategy for AAV in Europe and intends to engage with the EMA regarding both vilobelimab and izicopan. |
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• | Assess potential partnerships for joint development of izicopan. Since broad development of izicopan in different indications in parallel is time- and resource-consuming, we intend to assess potential development partners for izicopan and vilobelimab in selected indications and/or territories to support parallel development and maximize program value. |
• | Assess development options for vilobelimab in further indications. We are continuously evaluating options regarding the development of vilobelimab. Based on the logistical and financial effort necessary to successfully complete pivotal Phase 3 development programs in each indication, such options include potential collaborations with pharmaceutical partners. |
• | Explore the possibility to expand the applications of vilobelimab in the area of ARDS. We intend to explore the possibility of expanding the label into other critical care indications for which we have generated pre-clinical data in the past. Most notably, we are considering the utility of additional studies such as the Phase 2 BARDA study in broader ARDS, or studies with commercial partners, to expand the label into a product for virally induced ARDS. |
• | Seek commercial partners for GOHIBIC. In December 2025, InflaRx discontinued its active sales activities for GOHIBIC, while keeping the product available for ordering. As of June 30, 2026, we received notice from the FDA regarding termination of the EUA for GOHIBIC. The termination of the EUA will be effective 12 months from the date of publication of the Federal Register notice, i.e., July 1, 2027. |
• | Assess development options for vilobelimab in AAV and other indications. We intend to engage with the EMA regarding vilobelimab as part of our assessment of the most efficient development plan to bring the C5a/C5aR inhibition mechanism to patients. We consider vilobelimab to be a Phase 3-ready asset in AAV, where it has completed two Phase 2 studies in the U.S. and Europe, and continue to evaluate potential collaborations with pharmaceutical partners for selected indications and/or territories. |
• | Pursue the further development of IFX002 to get prepared for potential clinical development. We are developing IFX002 for the treatment of chronic 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 preclinical development. We consider IFX002 to be a life-cycle management product to vilobelimab, given the long remaining patent life of IFX002. |
• | the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; |
• | the sections of the Exchange Act imposing short-swing profit liability on insiders who profit from trades made in a short period of time and prohibiting short sales by insiders; provided, however, that effective March 18, 2026, pursuant to the Holding Foreign Insiders Accountable Act, our directors and officers are required to comply with the reporting requirements of Section 16(a) of the Exchange Act; |
• | the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specific information, or current reports on Form 8-K, upon the occurrence of specified significant events; and |
• | certain more stringent executive compensation disclosure rules; instead, we are permitted to follow our home country practice on such matters. |
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Assumed public offering price per ordinary share | $2.01 | €1.76 | ||||
Net tangible book value per ordinary share as of June 30, 2026 | $1.12 | €0.99 | ||||
Increase in net tangible book value per ordinary share attributable to investors purchasing ordinary shares in this offering | $0.15 | €0.13 | ||||
As adjusted net tangible book value per ordinary share as of June 30, 2026 after giving effect to this offering | $1.27 | €1.12 | ||||
Dilution per ordinary share to investors purchasing ordinary shares in this offering | $0.74 | €0.65 | ||||
• | 13,850,883 ordinary shares issuable upon the exercise of option awards (vested and unvested) under our 2017 long-term incentive plan as of June 30, 2026; |
• | 888,632 ordinary shares issuable upon the exercise of vested options outstanding as of June 30, 2026, under our 2016 stock option plan; |
• | 148,433 ordinary shares issuable upon the exercise of vested options outstanding as of June 30, 2026, under our 2012 stock option plan; and |
• | 6,750,000 ordinary shares issuable upon exercise of the pre-funded warrants outstanding as of June 30, 2026. |
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(i) | a holder of our ordinary shares if such holder has a substantial interest (aanmerkelijk belang) or deemed substantial interest (fictief aanmerkelijk belang) in us under the Dutch Income Tax Act 2001 (Wet inkomstenbelasting 2001). Generally, a holder is considered to hold a substantial interest in a company, if such holder alone or, in the case of an individual, together with such holder’s partner for Dutch income tax purposes, or any relatives by blood or marriage in the direct line (including foster children), directly or indirectly, holds (i) an interest of 5% or more of the total issued and outstanding capital of that company or of 5% or more of the issued and outstanding capital of a certain class of shares; or (ii) rights, to acquire, directly or indirectly, such interest; or (iii) certain profit sharing rights that relate to 5% or more of the company’s annual profits or to 5% or more of the company’s liquidation proceeds. A deemed substantial interest may arise if a substantial interest (or part thereof) in a company has been disposed of, or is deemed to have been disposed of, on a non-recognition basis; |
(ii) | a holder of our ordinary shares if the ordinary shares held by such holder qualify or qualified as a participation (deelneming) for purposes of the Dutch Corporate Income Tax Act 1969 (Wet op de vennootschapsbelasting 1969). Generally, a holder’s shareholding, or right to acquire, of 5% or more in a company’s nominal paid-up share capital qualifies as a participation. A holder may also have a participation if such holder does not have a shareholding of 5% or more but a related entity (statutorily defined term) has a participation, or the company in which the shares are held is a related entity (statutorily defined term); |
(iii) | a holder of our ordinary shares which is or who is entitled to the dividend withholding tax exemption (inhoudingsvrijstelling) with respect to any income (opbrengst) derived from the ordinary shares (as |
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(iv) | pension funds, investment institutions (fiscale beleggingsinstellingen), and tax-exempt investment institutions (vrijgestelde beleggingsinstellingen) (each as defined in the Dutch Corporate Income Tax Act 1969) and other entities that are, in whole or in part, not subject to or exempt from Dutch corporate income tax, entities that have a function comparable to an investment institution or a tax-exempt investment institution, as well as entities that are exempt from corporate income tax in their country of residence, such country of residence being another state of the European Union, Norway, Liechtenstein, Iceland or any other state with which the Netherlands has agreed to exchange information in line with international standards; |
(v) | a holder of our ordinary shares if such holder is an individual for whom the ordinary shares or any benefit derived from the ordinary shares is a remuneration or deemed to be a remuneration for (employment) activities performed by such holder or certain individuals related to such holder (as defined in the Dutch Income Tax Act 2001); |
(vi) | holders of our ordinary shares that are entities resident in Aruba, Curaçao, or Sint Maarten, conducting a business through a permanent establishment (vaste inrichting) or permanent representative (vaste vertegenwoordiger) in Bonaire, Sint Eustatius, or Saba, to which the ordinary shares are attributable; and |
(vii) | a holder of options and other awards under our share-based compensation plans, including a holder of (i) option awards under our 2017 long-term incentive plan, (ii) options under our 2012 stock option plan, (iii) options under our 2016 stock option plan and (iv) of our pre-funded warrants. |
• | distributions in cash or in kind, deemed and constructive distributions and repayments of paid-in capital not recognized for Dutch dividend withholding tax purposes; |
• | liquidation proceeds, proceeds from the redemption of ordinary shares, or proceeds from the repurchase of ordinary shares (other than as temporary portfolio investment; tijdelijke belegging) by us or one of our subsidiaries or other affiliated entities, in each case to the extent such proceeds exceed the average paid-in capital of those ordinary shares as recognized for Dutch dividend withholding tax purposes; |
• | an amount equal to the nominal value of ordinary shares issued or an increase of the nominal value of ordinary shares, to the extent that no related contribution, recognized for Dutch dividend withholding tax purposes, has been made or will be made; and |
• | partial repayment of the paid-in capital recognized for Dutch dividend withholding tax purposes, if and to the extent that we have “net profits” (zuivere winst), unless (i) our general meeting of shareholders has resolved in advance to make such repayment and (ii) the nominal value of the ordinary shares concerned has been reduced by an equal amount by way of an amendment to our articles of association. The term “net profits” includes anticipated profits that have yet to be realized. |
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(i) | is considered to be resident (gevestigd) in a jurisdiction that is listed in the yearly updated Dutch Regulation on low-taxing states and non-cooperative jurisdictions for tax purposes (Regeling laagbelastende staten en niet-coöperatieve rechtsgebieden voor belastingdoeleinden), or a Listed Jurisdiction; or |
(ii) | has a permanent establishment located in a Listed Jurisdiction to which the ordinary shares are attributable; or |
(iii) | holds our ordinary shares with the main purpose or one of the main purposes of avoiding taxation for another person or entity and there is an artificial arrangement or transaction or a series of artificial arrangements or transactions; or |
(iv) | is not considered to be the beneficial owner of our ordinary shares in its jurisdiction of residence because such jurisdiction treats another entity as the beneficial owner of our ordinary shares (a hybrid mismatch); or |
(v) | is not resident in any jurisdiction (also a hybrid mismatch); or |
(vi) | is a reverse hybrid (within the meaning of Article 2(11) of the Dutch Corporate Income Tax Act 1969), if and to the extent (x) there is a participant in the reverse hybrid holding a Qualifying Interest in the reverse hybrid, (y) the jurisdiction of residence of such participant treats the reverse hybrid as transparent for tax purposes and (z) such participant would have been subject to the Dutch conditional withholding tax in respect of dividends distributed by us without the interposition of the reverse hybrid, all within the meaning of the Dutch Withholding Tax Act 2021 (Wet bronbelasting 2021). |
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• | “Related Entity” means an entity (i) that has a Qualifying Interest in us or (ii) in which a third party has a Qualifying Interest if such third party also has a Qualifying Interest in us. |
• | “Qualifying Interest” means a direct or indirectly held interest - either by an entity individually or, if an entity is part of a Qualifying Unity, jointly - that enables such entity or such Qualifying Unity to exercise a definitive influence over another entity’s decisions and allows it to determine that other entity’s activities (as interpreted by the European Court of Justice in case law on the right of freedom of establishment (vrijheid van vestiging)). |
• | “Qualifying Unity” means entities acting together with the main purpose or one of the main purposes of avoiding Dutch conditional withholding tax at the level of any of those entities (kwalificerende eenheid). |
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(i) | the ordinary shares are attributable to an enterprise from which the holder of ordinary shares derives a share of the profit, whether as an entrepreneur (ondernemer) or as a person who has a co-entitlement to the net worth (medegerechtigd tot het vermogen) of such enterprise without being a shareholder (as defined in the Dutch Income Tax Act 2001); or |
(ii) | the holder of our ordinary shares is considered to perform activities with respect to the ordinary shares that go beyond ordinary asset management (normaal, actief vermogensbeheer) or otherwise derives benefits from the ordinary shares that are taxable as benefits from miscellaneous activities (resultaat uit overige werkzaamheden). |
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(i) | such holder does not have an interest in an enterprise or deemed enterprise (as defined in the Dutch Income Tax Act 2001 and the Dutch Corporate Income Tax Act 1969, as applicable) which, in whole or in part, is either effectively managed in the Netherlands or carried on through a permanent establishment, a deemed permanent establishment or a permanent representative in the Netherlands and to which enterprise or part of an enterprise the ordinary shares are attributable; and |
(ii) | in the event the holder is an individual, such holder does not carry out any activities in the Netherlands with respect to the ordinary shares that go beyond ordinary asset management and does not otherwise derive benefits from the ordinary shares that are taxable as benefits from miscellaneous activities in the Netherlands. |
(i) | in the case of a gift of an ordinary share by an individual who at the date of the gift was neither resident nor deemed to be resident of the Netherlands, such individual dies within 180 days after the date of the gift, while being resident or deemed to be resident of the Netherlands; |
(ii) | in the case of a gift of an ordinary share that is made under a condition precedent, the holder of our ordinary shares is resident or is deemed to be resident of the Netherlands at the time the condition is fulfilled; or |
(iii) | the transfer is otherwise construed as a gift or inheritance made by, or on behalf of, a person who, at the time of the gift or death, is or is deemed to be resident of the Netherlands. |
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• | certain financial institutions; |
• | dealers or traders in securities who use a mark-to-market method of tax accounting; |
• | persons holding ordinary shares as part of a hedging transaction, straddle, wash sale, conversion transaction or other integrated transaction or persons entering into a constructive sale with respect to the ordinary shares; |
• | persons whose functional currency for U.S. federal income tax purposes is not the U.S. dollar; |
• | S corporations, entities or arrangements classified as partnerships for U.S. federal income tax purposes; |
• | tax-exempt entities, including an “individual retirement account” or “Roth IRA”; |
• | persons that own or are deemed to own ten percent or more of our shares (by vote or value); |
• | persons who are subject to Section 451(b) of the Code; or |
• | persons holding ordinary shares in connection with a trade or business conducted outside of the United States. |
• | a citizen or individual resident of the United States; |
• | a corporation created or organized in or under the laws of the United States, any state therein or the District of Columbia; |
• | an estate the income of which is subject to U.S. federal income taxation regardless of its source; or |
• | a trust if (1) a U.S. court can exercise primary supervision over the trust’s administration and one or more United States persons are authorized to control all substantial decisions of the trust, or (2) the trust has a valid election in effect under applicable Treasury regulations to be treated as a United States person. |
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• | our Annual Report on Form 20-F for the fiscal year ended December 31, 2025 filed on March 20, 2026; |
• | our Reports on Form 6-K filed on January 8, 2026, March 16, 2026, April 2, 2026, April 9, 2026, April 23, 2026, April 28, 2026, May 4, 2026, May 6, 2026, May 7, 2026; June 30, 2026, and August 6, 2026 (excluding exhibits and other disclosure in such Form 6-Ks that are explicitly deemed therein as not “filed” for purposes of Section 18 of the Exchange Act); and |
• | the description of our ordinary shares contained in Exhibit 2.4 to our Annual Report on Form 20-F for the year ended December 31, 2025, including any amendments or reports filed for the purpose of updating such description. |
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Page | |||
ABOUT THIS PROSPECTUS | 1 | ||
WHERE YOU CAN FIND MORE INFORMATION | 1 | ||
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS | 2 | ||
INFLARX N.V. | 4 | ||
RISK FACTORS | 8 | ||
USE OF PROCEEDS | 9 | ||
CAPITALIZATION | 10 | ||
DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION | 11 | ||
COMPARISON OF DUTCH CORPORATE LAW AND OUR ARTICLES OF ASSOCIATION AND U.S. CORPORATE LAW | 17 | ||
DESCRIPTION OF DEBT SECURITIES | 28 | ||
DESCRIPTION OF WARRANTS | 32 | ||
DESCRIPTION OF PURCHASE CONTRACTS | 33 | ||
DESCRIPTION OF UNITS | 34 | ||
FORMS OF SECURITIES | 35 | ||
PLAN OF DISTRIBUTION | 37 | ||
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE | 39 | ||
ENFORCEMENT OF CIVIL LIABILITIES | 40 | ||
EXPENSES | 42 | ||
LEGAL MATTERS | 43 | ||
EXPERTS | 43 | ||
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• | the success of our development and registrational strategy for izicopan’s treatment of AAV and other renal diseases, including atypical hemolytic uremic syndrome, or aHUS, IgA nephropathy, or IgAN, and C3 glomerulopathy, or C3G, including our Phase 2 planning in AAV, our assessment of a broader development and registrational strategy in Europe following the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency, or EMA to revoke the marketing authorization for Tavneos (avacopan) in the European Union, and our ability to establish proof of concept for izicopan across such indications; |
• | the success of our future clinical trials for vilobelimab’s treatment of debilitating or life-threatening inflammatory indications, including acute respiratory distress syndrome, or ARDS, and AAV; |
• | the potential strategic transactions or collaborations, including a potential partnership of izicopan or vilobelimab for pyoderma gangrenosum, or PG, HS, CSU or any other indications; |
• | the timing, progress and results of preclinical studies and clinical trials of vilobelimab, izicopan and any other product candidates, including for the development of vilobelimab or izicopan in several indications including virally induced ARDS, hidradenitis suppurativa, or HS, chronic spontaneous urticaria, or CSU, or others, and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; |
• | our interactions with and the receptiveness and approval by regulators regarding the results of clinical trials and potential regulatory approval or authorization pathways, including our intended engagement with the EMA regarding vilobelimab and izicopan; |
• | the timing and outcome of any discussions or submission of filings for regulatory approval of vilobelimab, izicopan or any other product candidate, if approved or authorized for commercial use; |
• | our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediated immunological and inflammatory diseases; |
• | our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of such protection; |
• | whether the U.S. Food and Drug Administration, or the FDA, the European Medicines Agency or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; |
• | the success of our future clinical trials for vilobelimab, izicopan and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials; |
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• | our expectations regarding the size of the patient populations for, the market opportunity for, the medical need for and clinical utility of vilobelimab, izicopan 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 the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of any development candidate in the United States and Europe; |
• | our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; |
• | our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved or authorized, any commercial sales; |
• | if any of our product candidates obtain regulatory approval or authorization, our ability to comply with and satisfy ongoing drug regulatory obligations and continued regulatory oversight; |
• | 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 relating to our competitors in the development of C5a and C5aR inhibitors and other therapeutic products being developed in similar medical conditions in which vilobelimab, izicopan or any other of our product candidates is being developed or our industry; |
• | risks related to our reliance on foreign third-party manufacturers and suppliers, including those located in China; and |
• | other risk factors discussed herein under “Risk Factors” or incorporated herein by reference. |
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• | Proceed with clinical development of izicopan in AAV and additional renal diseases. We have conducted a single ascending dose and multiple ascending dose study of our C5aR antagonist izicopan, and a Phase 2a trial in HS and CSU. We are also conducting required non-clinical studies. Our previously announced Phase 2 planning with izicopan in AAV continues as planned and uninterrupted across multiple geographies, and we are working to establish a rapid proof-of-concept for izicopan across additional renal disease targets, including aHUS, IgAN and C3G. |
• | Assess a broadened AAV strategy in Europe. Following the recommendation by the EMA’s Committee for Medicinal Products for Human Use to revoke the marketing authorization for Tavneos in the European Union, InflaRx is assessing the feasibility of broadening its development and registrational strategy for AAV in Europe and intends to engage with the EMA regarding both vilobelimab and izicopan. |
• | Assess potential partnerships for joint development of izicopan. Since broad development of izicopan in different indications in parallel is time- and resource-consuming, we intend to assess potential development partners for izicopan and vilobelimab in selected indications and/or territories to support parallel development and maximize program value. |
• | Assess development options for vilobelimab in further indications. We are continuously evaluating options regarding the development of vilobelimab. Based on the logistical and financial effort necessary to successfully complete pivotal Phase 3 development programs in each indication, such options include potential collaborations with pharmaceutical partners. |
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• | Explore the possibility to expand the applications of vilobelimab in the area of ARDS. We intend to explore the possibility of expanding the label into other critical care indications for which we have generated pre-clinical data in the past. Most notably, we are considering the utility of additional studies such as the Phase 2 BARDA study in broader ARDS, or studies with commercial partners, to expand the label into a product for virally induced ARDS. |
• | Seek commercial partners for GOHIBIC. In December 2025, InflaRx discontinued its active sales activities for GOHIBIC, while keeping the product available for ordering. As of June 30, 2026, we received notice from the FDA regarding termination of the EUA for GOHIBIC. The termination of the EUA will be effective 12 months from the date of publication of the Federal Register notice, i.e., July 1, 2027. |
• | Assess development options for vilobelimab in AAV and other indications. We intend to engage with the EMA regarding vilobelimab as part of our assessment of the most efficient development plan to bring the C5a/C5aR inhibition mechanism to patients. We consider vilobelimab to be a Phase 3-ready asset in AAV, where it has completed two Phase 2 studies in the U.S. and Europe, and continue to evaluate potential collaborations with pharmaceutical partners for selected indications and/or territories. |
• | Pursue the further development of IFX002 to get prepared for potential clinical development. We are developing IFX002 for the treatment of chronic 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 preclinical development. We consider IFX002 to be a life-cycle management product to vilobelimab, given the long remaining patent life of IFX002. |
• | the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; |
• | the sections of the Exchange Act imposing short-swing profit liability on insiders who profit from trades made in a short period of time and prohibiting short sales by insiders; provided, however, that effective March 18, 2026, pursuant to the Holding Foreign Insiders Accountable Act, our directors and officers are required to comply with the reporting requirements of Section 16(a) of the Exchange Act; |
• | the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specific information, or current reports on Form 8-K, upon the occurrence of specified significant events; and |
• | certain more stringent executive compensation disclosure rules; instead, we are permitted to follow our home country practice on such matters. |
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• | to develop, license, manufacture and commercialize pharmaceutical products; |
• | to develop and commercialize tests and analytical methods; |
• | to participate in, to finance, to hold any other interest in and to conduct the management or supervision of other entities, companies, partnerships and businesses; |
• | to acquire, administer, exploit, invest, encumber and dispose of assets and liabilities; |
• | to furnish guarantees, to provide security, to warrant performance in any other way and to assume liability, whether jointly and severally or otherwise, in respect of obligations of group companies or other parties; and |
• | to do anything that, in the widest sense, is connected with or may be conducive to the objectives described above. |
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• | our board of directors, in light of the circumstances at hand when the cooling-off period was invoked, could not reasonably have concluded that the relevant proposal or hostile offer constituted a material conflict with the interests of our company and its business; |
• | our board of directors cannot reasonably believe that a continuation of the cooling-off period would contribute to careful policy-making; or |
• | other defensive measures, having the same purpose, nature and scope as the cooling-off period, have been activated during the cooling-off period and have not since been terminated or suspended within a reasonable period at the relevant shareholders’ request (i.e., no ‘stacking’ of defensive measures). |
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• | Executive directors should be appointed for a maximum period of four years, without limiting the number of consecutive terms executive directors may serve. |
• | Non-executive directors should be appointed for two consecutive periods of no more than four years. |
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• | a director should report any potential conflict of interest in a transaction that is of material significance to the company and/or to such director to the other directors without delay, providing all relevant information in relation to the conflict; |
• | the board of directors should then decide, outside the presence of the director concerned, whether there is a conflict of interest; |
• | transactions in which there is a conflict of interest with a director should be agreed on arms’ length terms; and |
• | a decision to enter into such a transaction in which there is a conflict of interest with a director that is of material significance to the company and/or to such director shall require the approval of the board of directors, and such transactions should be disclosed in the company’s annual board report. |
• | the material facts as to the director’s relationship or interest are disclosed and a majority of disinterested directors consent; |
• | the material facts are disclosed as to the director’s relationship or interest and a majority of shares entitled to vote thereon consent; or |
• | the transaction is fair to the corporation at the time it is authorized by the board of directors, a committee of the board of directors or the shareholders. |
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• | options awarded to our executive directors as part of their compensation could (subject to the terms of the option awards) vest and become exercisable during the first three years after the date of grant; |
• | our directors may generally sell our ordinary shares held by them at any point in time, subject to applicable law, company policy and applicable lock-up arrangements; |
• | our non-executive directors may be granted compensation in the form of shares, options and other equity-based compensation; and |
• | our executive directors may be entitled to a severance payment in excess of their respective annual base salaries. |
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• | our board of directors, in light of the circumstances at hand when the cooling-off period was invoked, could not reasonably have concluded that the relevant proposal or hostile offer constituted a material conflict with the interests of our company and its business; |
• | our board of directors cannot reasonably believe that a continuation of the cooling-off period would contribute to careful policy-making; or |
• | other defensive measures, having the same purpose, nature and scope as the cooling-off period, have been activated during the cooling-off period and have not since been terminated or suspended within a reasonable period at the relevant shareholders’ request (i.e., no ‘stacking’ of defensive measures). |
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• | the authorization of a class of preferred shares that may be issued by our board of directors to the protective foundation, in such a manner as to dilute the interest of any potential acquirer; |
• | the staggered multi-year terms of our directors (with subsequent terms as may be nominated by our board of directors and approved by our general meeting of shareholders), as a result of which only part of our directors may be subject to election or re-election in any one year; |
• | a provision that our directors may only be removed at the general meeting of shareholders by a two-thirds majority of votes cast representing more than 50% of our outstanding share capital if such removal is not proposed by our board of directors; |
• | our directors being appointed on the basis of a binding nomination by our board of directors, which can only be overruled by the general meeting of shareholders by a resolution adopted by at least a two-thirds majority of the votes cast, provided such majority represents more than half of the issued share capital (in which case the board of directors shall make a new nomination); |
• | a provision allowing, among other matters, the former chairman of our board of directors or our former chief executive officer, as applicable, to manage our affairs if all of our directors are removed from office and to appoint others to be charged with the management and supervision of our affairs until new directors are appointed by the general meeting of shareholders on the basis of a binding nomination discussed above; and |
• | requirements that certain matters, including an amendment of our Articles of Association, may only be brought to our shareholders for a vote upon a proposal by our board of directors. |
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• | the transaction that will cause the person to become an interested shareholder is approved by the board of directors of the target prior to the transactions; |
• | after the completion of the transaction in which the person becomes an interested shareholder, the interested shareholder holds at least 85% of the voting stock of the corporation not including shares owned by persons who are directors and officers of interested shareholders and shares owned by specified employee benefit plans; or |
• | after the person becomes an interested shareholder, the business combination is approved by the board of directors of the corporation and holders of at least 66 and two-thirds percent of the outstanding voting stock, excluding shares held by the interested shareholder. |
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• | a transfer of the business or virtually the entire business to a third party; |
• | the entry into or termination of a long-term cooperation of the company or a subsidiary with another legal entity or company or as a fully liable partner in a limited partnership or general partnership, if such cooperation or termination is of a far-reaching significance for the company; and |
• | the acquisition or divestment by the company or a subsidiary of a participating interest in the capital of a company having a value of at least one-third of the amount of its assets according to its balance sheet and explanatory notes or, if the company prepares a consolidated balance sheet, according to its consolidated balance sheet and explanatory notes in the last adopted annual accounts of the company. |
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• | classification as senior or subordinated debt securities; |
• | ranking of the specific series of debt securities relative to other outstanding indebtedness, including subsidiaries’ debt; |
• | if the debt securities are subordinated, the aggregate amount of outstanding indebtedness, as of a recent date, that is senior to the subordinated securities, and any limitation on the issuance of additional senior indebtedness; |
• | the designation, aggregate principal amount and authorized denominations; |
• | the date or dates on which the principal of the debt securities may be payable; |
• | the rate or rates (which may be fixed or variable) per annum at which the debt securities shall bear interest, if any; |
• | the date or dates from which such interest shall accrue, on which such interest shall be payable, and on which a record shall be taken for the determination of holders of the debt securities to whom interest is payable; |
• | the place or places where the principal and interest shall be payable; |
• | our right, if any, to redeem the debt securities, in whole or in part, at our option and the period or periods within which, the price or prices at which and any terms and conditions upon which such debt securities may be so redeemed, pursuant to any sinking fund or otherwise; |
• | our obligation, if any, to redeem, purchase or repay any debt securities pursuant to any mandatory redemption, sinking fund or other provisions or at the option of a holder of the debt securities; |
• | if other than denominations of $2,000 and any higher integral multiple of $1,000, the denominations in which the debt securities will be issuable; |
• | if other than the currency of the United States, the currency or currencies in which payment of the principal and interest shall be payable; |
• | whether the debt securities will be issued in the form of global securities; |
• | provisions, if any, for the defeasance of the debt securities; |
• | any U.S. federal income tax and any material non-U.S. tax consequences, where necessary; and |
• | other specific terms, including any deletions from, modifications of or additions to the events of default or covenants described below or in the applicable indenture. |
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• | subject to Dutch law, any insolvency or bankruptcy proceedings, or any receivership, dissolution, winding up, total or partial liquidation, reorganization or other similar proceedings in respect of us or a substantial part of our property, whether voluntary or involuntary; |
• | (i) a default having occurred with respect to the payment of principal or interest on or other monetary amounts due and payable with respect to any senior indebtedness or (ii) an Event of Default (as defined below) (other than a default described in clause (i) above) having occurred with respect to any senior indebtedness that permits the holder or holders of such senior indebtedness to accelerate the maturity of such senior indebtedness. Such a default or Event of Default must have continued beyond the period of grace, if any, provided in respect of such default or Event of Default, and such a default or Event of Default shall not have been cured or waived or shall not have ceased to exist; and |
• | the principal of, and accrued interest on, any series of the subordinated debt securities having been declared due and payable upon an Event of Default pursuant to the subordinated indenture. This declaration must not have been rescinded and annulled as provided in the subordinated indenture. |
(1) | default in the payment of the principal on the debt securities when it becomes due and payable at maturity or otherwise; |
(2) | default in the payment of interest on the debt securities when it becomes due and payable, and such default continues for a period of 30 days; |
(3) | default in the performance, or breach, of any covenant in the indenture (other than defaults specified in clauses (1) or (2) above) and the default or breach continues for a period of 90 consecutive days or more after written notice to us by the trustee or to us and the trustee by the holders of 25% or more in aggregate principal amount of the outstanding debt securities of all series affected thereby; |
(4) | the occurrence of certain events of bankruptcy, insolvency, or similar proceedings with respect to us or any substantial part of our property; or |
(5) | any other Events of Default that may be set forth in the applicable prospectus supplement. |
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• | the rights of registration of transfer and exchange of debt securities, and our right of optional redemption, if any; |
• | substitution of mutilated, defaced, destroyed, lost or stolen debt securities; |
• | the rights of holders of the debt securities to receive payments of principal and interest; |
• | the rights, obligations and immunities of the trustee; and |
• | the rights of the holders of the debt securities as beneficiaries with respect to the property deposited with the trustee payable to them (as described below); when: |
• | either: |
• | all debt securities of any series issued that have been authenticated and delivered have been delivered by us to the trustee for cancellation; or |
• | all the debt securities of any series issued that have not been delivered by us to the trustee for cancellation have become due and payable or will become due and payable within one year or are to be called for redemption within one year under arrangements satisfactory to the trustee for the giving of notice of redemption by such trustee in our name and at our expense, and we have irrevocably deposited or caused to be deposited with the trustee as trust funds the entire amount sufficient to pay at maturity or upon redemption all debt securities of such series not delivered to the trustee for cancellation, including principal and interest due or to become due on or prior to such date of maturity or redemption; |
• | we have paid or caused to be paid all other sums then due and payable under such indenture; and |
• | we have delivered to the trustee an officers’ certificate and an opinion of counsel, each stating that all conditions precedent under such indenture relating to the satisfaction and discharge of such indenture have been complied with. |
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• | we must irrevocably have deposited or caused to be deposited with the trustee as trust funds in trust for the purpose of making the following payments, specifically pledged as security for, and dedicated solely to the benefit of, the holders of the debt securities of a series: |
• | money in an amount; |
• | U.S. government obligations; or |
• | a combination of money and U.S. government obligations, |
• | we have delivered to the trustee an opinion of counsel stating that, under then applicable U.S. federal income tax law, the holders of the debt securities of that series will not recognize gain or loss for U.S. federal income tax purposes as a result of the defeasance and will be subject to the same federal income tax as would be the case if the defeasance did not occur; |
• | no default relating to bankruptcy or insolvency and, in the case of a covenant defeasance, no other default has occurred and is continuing at any time; |
• | if at such time the debt securities of such series are listed on a national securities exchange, we have delivered to the trustee an opinion of counsel to the effect that the debt securities of such series will not be delisted as a result of such defeasance; and |
• | we have delivered to the trustee an officers’ certificate and an opinion of counsel stating that all conditions precedent with respect to the defeasance have been complied with. |
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• | the title of the warrants; |
• | the aggregate number of warrants offered; |
• | the designation, number and terms of the debt securities, ordinary shares or other securities purchasable upon exercise of the warrants and procedures by which those numbers may be adjusted; |
• | the exercise price of the warrants; |
• | the dates or periods during which the warrants are exercisable; |
• | the designation and terms of any securities with which the warrants are issued; |
• | if the warrants are issued as a unit with another security, the date on and after which the warrants and the other security will be separately transferable; |
• | if the exercise price is not payable in U.S. dollars, the foreign currency, currency unit or composite currency in which the exercise price is denominated; |
• | any minimum or maximum amount of warrants that may be exercised at any one time; |
• | any terms relating to the modification of the warrants; |
• | any terms, procedures and limitations relating to the transferability, exchange or exercise of the warrants; and |
• | any other specific terms of the warrants. |
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• | the terms of the units and of the ordinary shares, debt securities, warrants and/or purchase contracts comprising the units, including whether and under what circumstances the securities comprising the units may be traded separately; |
• | a description of the terms of any unit agreement governing the units; and |
• | a description of the provisions for the payment, settlement, transfer or exchange of the units. |
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• | through underwriters or dealers; |
• | directly to a limited number of purchasers or to a single purchaser; |
• | in “at-the-market” offerings, within the meaning of Rule 415(a)(4) of the Securities Act, to or through a market maker or into an existing trading market on an exchange or otherwise; |
• | through agents; or |
• | through any other method permitted by applicable law and described in the applicable prospectus supplement. |
• | the name or names of any underwriters, dealers or agents; |
• | the purchase price of such securities and the proceeds to be received by us, if any; |
• | any underwriting discounts or agency fees and other items constituting underwriters’ or agents’ compensation; |
• | any initial public offering price; |
• | any discounts or concessions allowed or reallowed or paid to dealers; and |
• | any securities exchanges on which the securities may be listed. |
• | negotiated transactions; |
• | at a fixed public offering price or prices, which may be changed; |
• | at market prices prevailing at the time of sale; |
• | at prices related to prevailing market prices; or |
• | at negotiated prices. |
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• | our Annual Report on Form 20-F for the fiscal year ended December 31, 2025 filed on March 20, 2026; |
• | our Forms 6-K filed on January 8, 2026; March 16, 2026; April 2, 2026; April 9, 2026; April 23, 2026; April 28, 2026; May 4, 2026; May 6, 2026; May 7, 2026; June 30, 2026; and August 6, 2026 (excluding exhibits and other disclosure in such Form 6-Ks that are explicitly deemed therein as not “filed” for purposes of Section 18 of the Exchange Act); and |
• | the description of our ordinary shares contained in Exhibit 2.4 to our Annual Report on Form 20-F for the year ended December 31, 2025, including any amendments or reports filed for the purpose of updating such description. |
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Amount To Be Paid | |||
SEC registration fee | $27,839.79 | ||
Transfer agent and trustee fees | * | ||
Legal fees and expenses | * | ||
Accounting fees and expenses | * | ||
Printing expenses | * | ||
Miscellaneous | * | ||
Total | $ * | ||
* | To be provided in a prospectus supplement describing an offering of securities or a report on Form 6-K that is incorporated by reference herein. |
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