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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 Executive Officer 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 clinical utility of INF904 in chronic spontaneous urticaria and hidradenitis suppurativa are anticipated in the fall, potentially unlocking significant value in this pipeline program and driving INF904 one step further as an effective and safe oral option for patients with these painful and debilitating skin conditions.”
Select recent highlights and business update
INF904 Phase 2a trial – Data expected to provide significant clarity on clinical utility in CSU and HS
Given anticipated summer enrollment trends, we expect to report topline results from the ongoing Phase 2a basket study in HS and CSU by the end of September to early November. The data will include 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 the potential 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) containing both anti-IgE naïve and anti-IgE experienced patients. Enrollment in a third CSU dosing cohort (120 mg) targeting Type Iib phenotype patients very stringently selected as highly refractory to anti-IgE therapy is ongoing. The inclusion criteria for this third CSU arm have recently been broadened. Data from this last cohort in CSU will be announced in due course and, given sufficient demonstrated potential in 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-label study evaluating multiple INF904 dosing regimens over 4 weeks of treatment in a total of 75 patients (45 with CSU and 30 with HS). The goal of the trial is to generate additional safety and PK data and to demonstrate signs of clinical benefit, with the additional objective of informing Phase 2b trial go/no go decisions and study planning by year-end 2025.
InflaRx believes CSU and HS may each represent addressable markets 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 first patient in the JUST BREATHE Phase 2 platform clinical trial investigating novel therapeutic candidates for ARDS. The clinical trial is being implemented by the PPD clinical research business of Thermo Fisher Scientific and aims to evaluate the safety and efficacy of three host-directed therapeutic candidates at up to 60 U.S. sites, targeting a total enrollment of 600 hospitalized adult patients with ARDS.
Vilobelimab for pyoderma gangrenosum (PG)
In May 2025, InflaRx announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for vilobelimab in PG recommended that the trial be stopped due to futility. This action was based on analysis of the first 30 patients enrolled in the study, with no unexpected adverse events noted by the IDMC. The Phase 3 PG study has been closed, and InflaRx is working diligently towards database lock so that all data can be analyzed and unblinded later this year. In addition, the Company continues to carefully assess the opportunity to reallocate resources from PG activities toward INF904 development.
Development progress with anti-C5a antibody BDB-001 by collaborator Staidson BioPharmaceuticals
In July 2025, Staidson BioPharmaceuticals announced that a multicenter, randomized, open-label, placebo-controlled Phase 1/2 study met its primary efficacy endpoint, demonstrating that anti-C5a therapy can reduce corticosteroid use and enable corticosteroid-free treatment in patients with AAV. The study also met its key secondary efficacy endpoint, showing that complete remission rates in the treatment arms were non-inferior to those in the placebo group. We believe these findings highlight the potential of anti-C5a therapy to reduce corticosteroid dependency while maintaining effective disease control in 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, InflaRx granted 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 royalties on 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 remission rate, 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 (standard steroids). 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 complete remission rate, also based on LOCF analysis, all experimental groups showed numerically higher complete remission rates than the standard treatment 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 experimental groups vs. 47.4% in control group). The incidence of serious adverse events was 24.7%; the lowest was in the low dose without steroid group (6.3%), and the rest were comparable to control (19.0%–35.3% vs. 36.8%).
GOHIBIC (vilobelimab) in the EU
GOHIBIC (vilobelimab) is approved in the European Union (EU) under exceptional circumstances for the treatment of adults with SARS-CoV-2-induced ARDS who are receiving systemic corticosteroids as 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 treatment approved in the EU for the treatment of SARS-CoV-2-induced ARDS. InflaRx continues to pursue commercial partnering and distribution options in this geography and does not expect this approach will have a materially negative impact on its cash burn rate.
Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “With our solid balance sheet, disciplined financial management, and a cash runway 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 decrease of €3 thousand. Sales to distributors do not constitute revenue for the Company. All revenues are attributed to sales in the United States.
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 primarily quantities of unfinished goods on hand exceeding quantities expected to be sold prior to expiry and were determined by a multiple-scenario analysis. 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 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 was previously provided through a third party and offset by higher personnel expenses.
Research and development expenses
Research and development expenses incurred for the six 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 for the 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 amount of €4.3 million.
Other income
Other income for the six months ended June 30, 2025 amounted to €1.5 million, compared to €53 thousand for the six months ended June 30, 2024. Other income was primarily due to other income from research allowances.
Net financial result
Net financial result decreased by €1.2 million to 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 ended June 30, 2024. This decrease was 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 denominated securities holdings 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 February 2025.
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 amounted to approximately €53.7 million, comprised of €13.0 million in cash and cash equivalents and €40.7 million in 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 million in the six months ended June 30, 2025, compared to the six months ended June 30, 2024, due to a public offering of ordinary shares and pre-funded warrants in the six months ended June 30, 2025.
Additional financial information
Additional information regarding these results and other relevant information is included in the notes to the financial statements in “Item 18. Financial Statements”, which are included in InflaRx’s most recent annual report on Form 20-F as filed on March 20, 2025 with the U.S. Securities and Exchange Commission.
Unaudited condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024
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)
Unaudited condensed consolidated statements of financial position as of June 30, 2025 and December 31, 2024
June 30, 2025
(unaudited)
December 31, 2024
(in €)
Unaudited condensed consolidated statements of changes in shareholders’ equity for the six months ended June 30, 2025 and 2024
(in € except for share data)
Unaudited condensed consolidated statements of cash flows for the three months ended June 30, 2025 and 2024
For the six months ended June 30,
2025
(unaudited)
2024
(unaudited)
(in €)
About GOHIBIC (vilobelimab)
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. In addition to development in COVID-19, vilobelimab is also being developed for various debilitating or life-threatening inflammatory indications, including PG.
In April 2023, the FDA issued the EUA for GOHIBIC (vilobelimab) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). In January 2024, InflaRx announced the launch of The InflaRx Commitment Program, pursuant to which the cost of GOHIBIC (vilobelimab) will be refunded for up to six (6) administered inpatient doses (the full treatment course) to institutions that meet the eligibility requirements, for patients who were administered GOHIBIC (vilobelimab) in line with its EUA and who died due to COVID-19 in the intensive care unit.
The Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic ARDS receiving IMV or ECMO is under regulatory review by the European Committee for Medicinal Products for Human Use under the centralized procedure, which applies to all 27 member states of the European Union.
About INF904
INF904 is an orally administered, small molecule inhibitor of the C5a receptor 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 P450 3A4/5 (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 signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day (QD) to 90 mg twice per day (BID) for 14 days. PK / pharmacodynamic data support best-in-class potential of INF904 with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period.
About InflaRx
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 product candidate, vilobelimab, is 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 in different indications. InflaRx is also developing INF904, an orally administered, small molecule inhibitor of the C5a receptor. 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.com.
InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).
InflaRx N.InflaRx N.V.
Jan Medina, CFA
Vice President, Head of Investor Relations
Email: IR@inflarx.de
MC Services AG
Katja Arnold, Laurie Doyle, Dr. Regina Lutz
Email:inflarx@mc-services.eu
Europe: +49 89-210 2280
US: +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 include statements regarding our intentions, beliefs, projections, outlook, analyses, current expectations and the risks, uncertainties and other factors described under the heading “Risk factors” and “Cautionary statement regarding forward looking statements“ 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.