InflaRx N.V 6-K, filed May 6, 2026
InflaRx N.V. (IFRX)
6-K
2026-05-06
For: 2026-05-06
View Original
Added on
May 06, 2026
About this 6-K
InflaRx N.V filed this 6-K on May 6, 2026.
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
Report of Foreign Private
Issuer Pursuant to Rule
13a-16 or 15d-16 of the
Securities Exchange Act
of 1934
For the month of May 2026
Commission File
Number: 001-38283
InflaRx N.V.
(Exact name of Registrant as Specified in Its Charter)
Winzerlaer Str. 2
07745 Jena,
Germany
(+49) 3641508180
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
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Form 20-F ☒ Form 40-F ☐
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EXPLANATORY NOTE
On May 6, 2026, InflaRx N.V. (the “Company”) issued a press release titled “InflaRx Announces Advancement of Izicopan in ANCA-Associated Vasculitis and Select Renal Diseases.”
The Company today announced that it intends to develop izicopan, an oral C5a receptor (C5aR) inhibitor with potential best-in-class properties, in ANCA-associated vasculitis (AAV), a life-threatening kidney disorder. The
Company is conducting Phase 2 planning for izicopan in AAV and is evaluating the feasibility of multiple development approaches, including the potential for an expedited path to the commercial market, in an effort to best address the evolving
regulatory environment surrounding the currently approved comparator, avacopan.
In addition, the Company announced its goal of establishing rapid proof of concept for izicopan across a broader range of complement-mediated life-threatening kidney diseases by conducting open-label studies that are
expected to begin generating clinical data next year in certain indications. These additional renal disease targets include atypical hemolytic uremic syndrome (aHUS), IgA nephropathy (IgAN)
and C3 glomerulopathy (C3G), where early evidence already exists for the role of C5a/C5aR inhibition and where izicopan’s favorable clinical profile could be a significant differentiator. Toward these efforts, the Company anticipates conducting a
pharmacokinetic bridging study in China this year.
A copy of the press release and a copy of the Company’s presentation are attached as Exhibit 99.1 and Exhibit 99.2, respectively. Both Exhibit 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), 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, or the Exchange
Act.
FORWARD-LOOKING STATEMENTS
This Report 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 Report and may include statements regarding our
intentions, beliefs, projections, outlook, analyses, current expectations and the risks, uncertainties and other factors described under the headings, “Risk factors” and “Cautionary statement regarding forward looking statements,” in our periodic
filings with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this Report and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or
achievements to be materially different 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 obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.
EXHIBIT INDEX
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Exhibit No.
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Description
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Press Release, dated May 6, 2026.
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Corporate Presentation, dated May 6, 2026.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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INFLARX N.V.
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Date: May 6, 2026
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By:
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/s/ Niels Riedemann
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Name: Niels Riedemann
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Title: Chief Executive Officer
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Exhibit 99.1
InflaRx Announces Advancement of Izicopan in ANCA-Associated Vasculitis and Select Renal Diseases
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InflaRx intends to develop izicopan in ANCA-associated vasculitis (AAV), with a secondary goal of establishing rapid proof of concept in additional life-threatening renal diseases
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Capital Markets Day highlighting the promise and potential of izicopan in AAV and broader renal disorders now planned for summer 2026
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The Company estimates it will have sufficient funds for currently planned clinical development activities and ongoing operations through 2029
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InflaRx will continue to engage in dialog with potential collaborators to advance its development goals with izicopan across all geographies
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The Company will host a webcast to discuss its new strategy in AAV and renal disease on Friday, May 8, at 8:30 AM ET / 2:30 PM CET
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Jena, Germany, May 6, 2026 – InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting
the complement system, today announced that it intends to develop izicopan, an oral C5a receptor (C5aR) inhibitor with potential best-in-class properties, in AAV, a life-threatening kidney disorder. InflaRx is conducting Phase 2 planning for izicopan
in AAV and is evaluating the feasibility of multiple development approaches, including the potential for an expedited path to the commercial market, in an effort to best address the evolving regulatory environment surrounding the currently approved
comparator, avacopan.
In addition, the Company has announced its goal of establishing rapid proof of concept for izicopan across a broader range of complement-mediated life-threatening kidney diseases by
conducting open-label studies that are expected to begin generating clinical data next year in certain indications. These additional renal disease targets include atypical hemolytic uremic syndrome (aHUS), IgA nephropathy
(IgAN) and C3 glomerulopathy (C3G), where early evidence already exists for the role of C5a/C5aR inhibition and where izicopan’s favorable clinical profile could be a significant differentiator. Toward these efforts,
InflaRx anticipates conducting a pharmacokinetic bridging study in China this year.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: “We have elected to pursue development in ANCA-associated
vasculitis following our thorough evaluation of the high unmet need in this life-threatening disease and izicopan’s promise as a significantly differentiated inhibitor of C5aR, with potential advantages in efficacy, safety and convenience.
Furthermore, with a strong body of evidence supporting the role of the C5a/C5aR axis in multiple kidney diseases, our additional goal is to establish proof of concept in other renal disorders, such as atypical hemolytic uremic syndrome, IgA
nephropathy and C3 glomerulopathy.”
InflaRx estimates it will have sufficient funds to execute currently planned development programs through meaningful milestones, including proof-of-concept data readouts in aHUS,
IgAN and C3G, the Phase 2 data readout in AAV, as well as ongoing operations, through 2029.
Capital Markets Day
InflaRx expects to host a Capital Markets Day to further detail the potential of izicopan’s best-in-class properties in AAV, aHUS, IgAN and C3G this summer.
Webcast
InflaRx will host a webcast/conference call on Friday, May 8, at 8:30 AM ET / 2:30 PM CET. To participate in the call, participants may pre-register here to receive an
invite link and dial-in details.
The live webcast and audio archive of the presentation can be accessed on the InflaRx website at https://www.inflarx.de/Home/Investors/Events.html.
Izicopan for hidradenitis suppurativa (HS)
InflaRx has largely concluded its interactions with FDA regarding an optimized clinical development program for izicopan in HS, and believes a viable path forward exists. The Company believes HS remains
a significant opportunity for izicopan, with a market potential that could exceed $1.5 billion per year, with further development currently envisioned only in collaboration with a partner.
About izicopan
Izicopan is an orally administered, small molecule inhibitor of the C5a receptor (C5aR) that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in
contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan does not exhibit time-dependent inhibition of cytochrome P450 3A4 (CYP3A4), which plays an important role in the metabolism of a variety of metabolites and
drugs, including glucocorticoids. Izicopan has also demonstrated a favorable reactive metabolite profile in human liver microsomes. Reported results from a first-in-human study demonstrated that izicopan was well tolerated in treated subjects and
exhibited no safety signals of 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 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of
izicopan, with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern. In patients with
hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment
period, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7)
broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7). In addition, InflaRx has begun planning for development of izicopan in AAV and additional
renal indications.
About InflaRx N.V.
InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and
specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx‘s lead program is izicopan, an orally
administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The Company is developing izicopan for the
treatment of AAV and additional renal diseases. InflaRx also 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
activity and tolerability in multiple clinical studies.
InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and
InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).
Contacts:
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InflaRx N.V.
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MC Services AG
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Jan Medina, CFA
Vice President, Head of Investor Relations
Email: IR@inflarx.de
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Katja Arnold, Laurie Doyle, Dr. Regina Lutz
Email: inflarx@mc-services.eu
Europe: +49 89-210 2280
U.S.: +1-339-832-0752
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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 include
statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the success of our future clinical trials for izicopan’s treatment of anti-neutrophil cytoplasmic AAV and other
renal diseases, including aHUS, IgAN and C3G, 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 other debilitating or life-threatening
inflammatory indications, including acute respiratory distress syndrome; potential strategic transactions or collaborations, including a potential partnership of izicopan, or vilobelimab for PG; the success of our future clinical trials for
izicopan, and whether 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 vilobelimab, izicopan and any
other of our product candidates 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 regulators regarding the results of clinical 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 implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; 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; 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 vilobelimab and for the finished product GOHIBIC (vilobelimab); 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, any
commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking
marketing approval or commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections
relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the SEC. These statements speak only as
of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different 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 obligation to update these
forward-looking statements, even if new information becomes available in the future, except as required by law.
Exhibit 99.2
