InflaRx Reports Second Quarter 2025 Financial Results and Provides Business Update
InflaRx (NASDAQ:IFRX) reported Q2 2025 financial results and provided key updates on its pipeline. The company's cash position stands at €53.7 million, with runway extending into 2027. Key developments include anticipated INF904 Phase 2a data in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected by early November 2025.
Financial highlights show a net loss of €23.0 million (€0.35 per share) for H1 2025. The company's partner Staidson BioPharmaceuticals reported favorable Phase 1/2 results for BDB-001 in ANCA-associated vasculitis, planning to advance to Phase 3. The previously announced Phase 3 pyoderma gangrenosum trial was stopped due to futility, with full data analysis expected later this year.
Additionally, enrollment began in the BARDA-funded JUST BREATHE Phase 2 platform trial investigating vilobelimab for acute respiratory distress syndrome (ARDS). The company maintains EU approval for GOHIBIC (vilobelimab) in SARS-CoV-2-induced ARDS and is pursuing commercial partnerships.
InflaRx (NASDAQ:IFRX) ha comunicato i risultati finanziari del secondo trimestre 2025 e fornito aggiornamenti chiave sul proprio portafoglio di progetti. La posizione di cassa della società è di 53,7 milioni di euro, con una disponibilità finanziaria che si estende fino al 2027. Tra gli sviluppi principali si segnalano i dati attesi della fase 2a di INF904 per l'orticaria spontanea cronica (CSU) e l'idrosadenite suppurativa (HS), previsti per i primi di novembre 2025.
I dati finanziari evidenziano una perdita netta di 23,0 milioni di euro (0,35 euro per azione) nel primo semestre 2025. Il partner della società, Staidson BioPharmaceuticals, ha riportato risultati positivi di fase 1/2 per BDB-001 nella vasculite associata ad ANCA, con piani per passare alla fase 3. Lo studio di fase 3 sul pioderma gangrenoso, precedentemente annunciato, è stato interrotto per inefficacia, con l'analisi completa dei dati prevista per la fine dell'anno.
Inoltre, è iniziata l'arruolamento nello studio di fase 2 JUST BREATHE, finanziato da BARDA, che indaga vilobelimab per la sindrome da distress respiratorio acuto (ARDS). La società mantiene l'approvazione europea per GOHIBIC (vilobelimab) nell'ARDS indotto da SARS-CoV-2 e sta cercando partnership commerciali.
InflaRx (NASDAQ:IFRX) informó los resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones clave sobre su cartera de proyectos. La posición de efectivo de la compañía es de 53,7 millones de euros, con recursos financieros que se extienden hasta 2027. Entre los desarrollos principales se esperan los datos de la fase 2a de INF904 en urticaria espontánea crónica (CSU) e hidradenitis supurativa (HS) para principios de noviembre de 2025.
Los aspectos financieros muestran una pérdida neta de 23,0 millones de euros (0,35 euros por acción) en el primer semestre de 2025. El socio de la empresa, Staidson BioPharmaceuticals, reportó resultados favorables de fase 1/2 para BDB-001 en vasculitis asociada a ANCA, con planes para avanzar a fase 3. El ensayo de fase 3 para pioderma gangrenoso, anunciado previamente, fue detenido por falta de eficacia, y se espera el análisis completo de los datos para finales de año.
Además, comenzó la inscripción en el ensayo de plataforma de fase 2 JUST BREATHE, financiado por BARDA, que investiga vilobelimab para el síndrome de dificultad respiratoria aguda (ARDS). La compañía mantiene la aprobación en la UE para GOHIBIC (vilobelimab) en ARDS inducido por SARS-CoV-2 y está buscando asociaciones comerciales.
InflaRx (NASDAQ:IFRX)는 2025년 2분기 재무 실적을 발표하고 파이프라인의 주요 업데이트를 제공했습니다. 회사의 현금 보유액은 5370만 유로이며, 자금 운용 기간은 2027년까지 연장됩니다. 주요 개발 사항으로는 2025년 11월 초에 만성 자발성 두드러기(CSU) 및 농포성 한선염(HS) 대상 INF904 2a상 데이터가 예상됩니다.
재무 하이라이트는 2025년 상반기 순손실 2300만 유로(주당 0.35유로)을 보여줍니다. 회사의 파트너인 Staidson BioPharmaceuticals는 ANCA 관련 혈관염에 대한 BDB-001의 1/2상 결과가 긍정적이라고 보고했으며, 3상으로 진행할 계획입니다. 이전에 발표된 3상 피오데르마 궤양 시험은 무효 판정으로 중단되었으며, 전체 데이터 분석은 올해 말에 예정되어 있습니다.
또한 BARDA가 자금을 지원하는 JUST BREATHE 2상 플랫폼 시험에서 급성 호흡 곤란 증후군(ARDS) 치료를 위한 빌로벨리맙의 등록이 시작되었습니다. 회사는 SARS-CoV-2 유발 ARDS에 대한 GOHIBIC(빌로벨리맙)의 EU 승인을 유지하고 있으며 상업적 파트너십을 모색 중입니다.
InflaRx (NASDAQ:IFRX) a publié ses résultats financiers du deuxième trimestre 2025 et donné des mises à jour clés sur son pipeline. La trésorerie de l'entreprise s'élève à 53,7 millions d'euros, avec une autonomie financière jusqu'en 2027. Parmi les développements importants, les données attendues de la phase 2a d'INF904 dans l'urticaire chronique spontanée (CSU) et l'hidrosadénite suppurée (HS) sont prévues pour début novembre 2025.
Les points financiers montrent une perte nette de 23,0 millions d'euros (0,35 euro par action) pour le premier semestre 2025. Le partenaire de la société, Staidson BioPharmaceuticals, a rapporté des résultats favorables de phase 1/2 pour BDB-001 dans la vascularite associée aux ANCA, avec l'intention de passer en phase 3. L'essai de phase 3 sur le pyoderma gangrenosum, précédemment annoncé, a été arrêté pour inefficacité, une analyse complète des données étant attendue plus tard cette année.
De plus, le recrutement a commencé dans l'essai de plateforme de phase 2 JUST BREATHE financé par BARDA, qui étudie le vilobelimab pour le syndrome de détresse respiratoire aiguë (SDRA). La société conserve l'approbation européenne pour GOHIBIC (vilobelimab) dans le SDRA induit par le SARS-CoV-2 et recherche des partenariats commerciaux.
InflaRx (NASDAQ:IFRX) hat die Finanzergebnisse für das zweite Quartal 2025 veröffentlicht und wichtige Updates zu seiner Pipeline gegeben. Die Liquiditätsposition des Unternehmens beträgt 53,7 Millionen Euro, mit ausreichender Finanzierung bis ins Jahr 2027. Zu den wichtigsten Entwicklungen zählen die erwarteten INF904 Phase 2a-Daten bei chronischer spontaner Urtikaria (CSU) und Hidradenitis suppurativa (HS), die Anfang November 2025 erwartet werden.
Finanzielle Highlights zeigen einen Nettoverlust von 23,0 Millionen Euro (0,35 Euro pro Aktie) für das erste Halbjahr 2025. Der Partner des Unternehmens, Staidson BioPharmaceuticals, berichtete positive Phase 1/2-Ergebnisse für BDB-001 bei ANCA-assoziierter Vaskulitis und plant den Übergang zu Phase 3. Die zuvor angekündigte Phase-3-Studie zum Pyoderma gangraenosum wurde aufgrund von Erfolglosigkeit abgebrochen, die vollständige Datenanalyse wird noch in diesem Jahr erwartet.
Darüber hinaus wurde mit der Rekrutierung für die BARDA-finanzierte JUST BREATHE Phase-2-Plattformstudie begonnen, die Vilobelimab bei akutem respiratorischem Distress-Syndrom (ARDS) untersucht. Das Unternehmen behält die EU-Zulassung für GOHIBIC (Vilobelimab) bei SARS-CoV-2-induziertem ARDS und verfolgt kommerzielle Partnerschaften.
- Cash runway extended into 2027 with €53.7 million in available funds
- Positive Phase 1/2 results for partnered BDB-001 in ANCA-associated vasculitis
- GOHIBIC (vilobelimab) maintains EU approval as first treatment for SARS-CoV-2-induced ARDS
- Enrollment initiated in BARDA-funded Phase 2 ARDS trial
- Phase 3 pyoderma gangrenosum trial stopped due to futility
- Net loss of €23.0 million in H1 2025
- Inventory write-downs of €2.4 million
- Revenue decreased to €39 thousand from €42 thousand year-over-year
Insights
InflaRx's upcoming INF904 data readout in CSU/HS could be transformative while cash runway into 2027 provides operational stability.
InflaRx's Q2 update reveals a pivotal moment approaching for their oral C5aR inhibitor INF904, with Phase 2a readouts in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected between late September and early November 2025. These results will be crucial decision points for advancing to Phase 2b trials, potentially unlocking significant value in markets the company estimates at
The company's financial position remains solid with
The partnered C5a antibody BDB-001 showed promising Phase 1/2 results in ANCA-associated vasculitis (AAV), demonstrating the ability to reduce corticosteroid use while maintaining efficacy. This program, developed by Staidson BioPharmaceuticals using InflaRx's cell line, could generate mid-single-digit royalties if successfully commercialized.
Net loss for the six-month period was
The lowered cash burn rate (
- INF904 Phase 2a data in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected by the end of September to early November 2025
- Phase 1/2 data announced by Staidson BioPharmaceuticals for InflaRx-partnered C5a antibody BDB-001 in ANCA-associated vasculitis (AAV) were favorable, with Staidson expecting Phase 3 study initiation
- InflaRx working diligently toward unblinding of stopped Phase 3 pyoderma gangrenosum (PG) trial so that all data can be analyzed later this year
- Enrollment began in BARDA funded JUST BREATHE Phase 2 platform clinical trial investigating vilobelimab and additional novel therapeutic candidates for acute respiratory distress syndrome (ARDS)
- Cash, cash equivalents and marketable securities totaled
€53.7 million on June 30, 2025 - InflaRx estimates it has sufficient funds for currently planned operations into 2027, with review ongoing to determine feasibility of prioritizing additional resources toward INF904
JENA, Germany, Aug. 07, 2025 (GLOBE NEWSWIRE) -- 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
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
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:
Overall safety was positive, and risks were controllable. The incidence of Grade 3 or higher adverse events was
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
Cost of sales
Cost of sales during the six months ended June 30, 2025 amounted to
Sales and marketing expenses
Sales and marketing expenses incurred for the six months ended June 30, 2025 decreased by
Research and development expenses
Research and development expenses incurred for the six months ended June 30, 2025 decreased by
General and administrative expenses
General and administrative expenses incurred for the six months ended June 30, 2025 increased by
Other income
Other income for the six months ended June 30, 2025 amounted to
Net financial result
Net financial result decreased by
Net loss
We incurred a net loss of
Liquidity and capital resources
As of June 30, 2025, our total funds available amounted to approximately
Net cash used in operating activities
Net cash used in operating activities decreased to
Net cash from financing activities
Net cash from financing activities increased by
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.
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024
| For the three months ended June 30, | For the six months ended June 30, | ||||||
| 2025 (unaudited) | 2024 (unaudited) | 2025 (unaudited) | 2024 (unaudited) | ||||
| (in €, except for share data) | |||||||
| Revenues | 39,432 | 6,357 | 39,432 | 42,394 | |||
| Cost of sales | (2,399,583) | (348,153) | (2,408,874) | (568,674) | |||
| Gross profit (loss) | (2,360,151) | (341,796) | (2,369,442) | (526,280) | |||
| Sales and marketing expenses | (1,013,347) | (1,828,628) | (2,471,326) | (3,288,167) | |||
| Research and development expenses | (7,202,942) | (10,016,870) | (14,219,279) | (17,318,680) | |||
| General and administrative expenses | (3,279,485) | (3,226,098) | (8,342,090) | (6,805,249) | |||
| Other income | 937,938 | 16,730 | 1,479,035 | 53,023 | |||
| Other expenses | — | — | (26) | — | |||
| Operating result | (12,917,988) | (15,396,663) | (25,923,127) | (27,885,353) | |||
| Finance income | 522,221 | 848,243 | 1,015,985 | 1,754,148 | |||
| Finance expenses | (3,355) | (8,732) | (7,441) | (10,844) | |||
| Foreign exchange result | (2,869,983) | 711,411 | (4,778,812) | 2,535,787 | |||
| Other financial result | 852,834 | — | 6,963,097 | 103,285 | |||
| Income taxes | — | — | — | — | |||
| Income (loss) for the period | (14,416,271) | (13,845,741) | (22,730,298) | (23,502,977) | |||
| Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | |||||||
| Exchange differences on translation of foreign currency | (113,604) | 28,374 | (264,271) | 2,836 | |||
| Total comprehensive income (loss) | (14,529,876) | (13,817,367) | (22,994,569) | (23,500,141) | |||
| Share information | |||||||
| Weighted average number of shares outstanding | 67,747,130 | 58,883,272 | 65,542,269 | 58,883,272 | |||
| Income (loss) per share (basic/diluted) | (0.21) | (0.24) | (0.35) | (0.40) | |||
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of financial position as of June 30, 2025, and December 31, 2024
| June 30, 2025 (unaudited) | December 31, 2024 | ||
| (in €) | |||
| ASSETS | |||
| Non-current assets | |||
| Property and equipment | 247,027 | 256,280 | |
| Right-of-use assets | 559,286 | 758,368 | |
| Intangible assets | 50,106 | 50,781 | |
| Other assets | 177,716 | 204,233 | |
| Financial assets | 6,235,346 | 3,092,290 | |
| Total non-current assets | 7,269,480 | 4,361,952 | |
| Current assets | |||
| Inventories | 5,038,415 | 6,897,666 | |
| Current other assets | 5,519,954 | 5,103,402 | |
| Other assets from government grants and research allowance | 5,863,947 | 5,081,772 | |
| Tax receivables | 1,753,638 | 1,735,335 | |
| Financial assets | 34,993,289 | 34,462,352 | |
| Cash and cash equivalents | 13,003,450 | 18,375,979 | |
| Total current assets | 66,172,692 | 71,656,505 | |
| TOTAL ASSETS | 73,442,172 | 76,018,457 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Issued capital | 8,129,656 | 7,122,205 | |
| Share premium | 348,956,615 | 334,929,685 | |
| Other capital reserves | 47,704,375 | 44,115,861 | |
| Accumulated deficit | (354,922,519) | (332,192,221) | |
| Other components of equity | 7,176,239 | 7,440,510 | |
| Total equity | 57,044,365 | 61,416,039 | |
| Non-current liabilities | |||
| Lease liabilities | 203,878 | 399,066 | |
| Other liabilities | 36,877 | 36,877 | |
| Total non-current liabilities | 240,755 | 435,943 | |
| Current liabilities | |||
| Trade and other payables | 9,735,656 | 11,394,232 | |
| Lease liabilities | 395,234 | 406,020 | |
| Employee benefits | 1,114,635 | 2,064,678 | |
| Liabilities to warrant holders | 4,549,915 | — | |
| Other liabilities | 361,613 | 301,544 | |
| Total current liabilities | 16,157,053 | 14,166,475 | |
| Total liabilities | 16,397,808 | 14,602,417 | |
| TOTAL EQUITY AND LIABILITIES | 73,442,172 | 76,018,457 | |
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of changes in shareholders’ equity for the six months ended June 30, 2025 and 2024
| (in €, except for share data) | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other compo- nents of equity | Total equity | |||||||||
| Balance as of January 1, 2025 | 7,122,205 | 334,929,685 | 44,115,861 | (332,192,221 | ) | 7,440,510 | 61,416,039 | ||||||||
| Loss for the period | — | — | — | (22,730,298 | ) | — | (22,730,298 | ) | |||||||
| Exchange differences on translation of foreign currency | — | — | — | — | (264,271 | ) | (264,271 | ) | |||||||
| Total comprehensive loss | — | — | — | (22,730,298 | ) | (264,271 | ) | (22,994,569 | ) | ||||||
| Issuance of ordinary shares | 1,007,450 | 15,136,235 | — | — | — | 16,143,686 | |||||||||
| Transaction costs for ordinary shares | — | (1,109,305 | ) | — | — | — | (1,109,305 | ) | |||||||
| Equity-settled share-based payments | — | — | 3,588,514 | — | — | 3,588,514 | |||||||||
| Balance as of June 30, 2025 | 8,129,656 | 348,956,615 | 47,704,375 | (354,922,519 | ) | 7,176,239 | 57,044,365 | ||||||||
| Balance as of January 1, 2024 | 7,065,993 | 334,211,338 | 40,050,053 | (286,127,819 | ) | 7,382,166 | 102,581,730 | ||||||||
| Loss for the period | — | — | — | (23,502,977 | ) | — | (23,502,977 | ) | |||||||
| Exchange differences on translation of foreign currency | — | — | — | — | 2,836 | 2,836 | |||||||||
| Total comprehensive loss | — | — | — | (23,502,977 | ) | 2,836 | (23,500,141 | ) | |||||||
| Equity-settled share-based payments | — | — | 3,073,814 | — | — | 3,073,814 | |||||||||
| Balance as of June 30, 2024 | 7,065,993 | 334,211,338 | 43,123,867 | (309,630,796 | ) | 7,385,002 | 82,155,403 | ||||||||
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of cash flows for the six months ended June 30, 2025 and 2024
| For the six months ended June 30, | |||
| 2025 (unaudited) | 2024 (unaudited) | ||
| (in €) | |||
| Operating activities | |||
| Loss for the period | (22,730,298) | (23,502,977) | |
| Adjustments for: | |||
| Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | 228,801 | 262,932 | |
| Net finance income | (3,192,828) | (4,382,376) | |
| Share-based payment expense | 3,588,514 | 3,073,813 | |
| Net foreign exchange differences and other adjustments | 1,518,421 | (101,055) | |
| Changes in: | |||
| Other assets from government grants and research allowances | (782,175) | — | |
| Other assets and trade receivables | (408,339) | 1,189,849 | |
| Employee benefits | (950,043) | (484,102) | |
| Other liabilities | 60,068 | (2,711,447) | |
| Trade and other payables | (1,658,576) | (3,429,460) | |
| Inventories | 1,859,251 | 1,723,566 | |
| Interest received | 906,087 | 1,369,670 | |
| Interest paid | (7,652) | (11,048) | |
| Net cash used in operating activities | (21,568,767) | (27,002,634) | |
| Investing activities | |||
| Purchase of intangible assets, property and equipment | (25,673) | (28,310) | |
| Purchase of current financial assets | (35,514,042) | (23,254,210) | |
| Proceeds from the maturity of financial assets | 28,288,912 | 56,221,278 | |
| Net cash from / (used in) investing activities | (7,250,803) | 32,938,758 | |
| Financing activities | |||
| Proceeds from issuance of ordinary shares | 16,143,686 | — | |
| Proceeds from pre-funded warrants | 12,915,909 | — | |
| Transaction costs from issuance of ordinary shares and pre-funded warrants | (1,949,998) | — | |
| Repayment of lease liabilities | (199,904) | (193,053) | |
| Net cash from / (used in) financing activities | 26,909,693 | (193,053) | |
| Net increase in cash and cash equivalents | (1,909,878) | 5,743,071 | |
| Effect of exchange rate changes on cash and cash equivalents | (3,462,651) | 641,107 | |
| Cash and cash equivalents at beginning of period | 18,375,979 | 12,767,943 | |
| Cash and cash equivalents at end of period | 13,003,450 | 19,152,121 | |
About GOHIBIC (vilobelimab)
In the United States, vilobelimab has been granted an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) 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) under the trade name GOHIBIC. The emergency use of GOHIBIC (vilobelimab) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner. GOHIBIC (vilobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using GOHIBIC (vilobelimab) to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC website http://www.gohibic.com.
In the European Union, GOHIBIC (vilobelimab) has been granted marketing authorization (Marketing Authorization) under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving IMV with or without ECMO. The EU approval of GOHIBIC (vilobelimab) is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of
A Marketing Authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC (vilobelimab)’s approval in the European Commission, InflaRx will provide annual updates to European Medicines Agency on the previously announced clinical platform study by the Biomedical Advanced Research and Development Authority. Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.
The COVID-19 related work described herein was partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx.
Important Safety Information about GOHIBIC (vilobelimab)
There is limited clinical data available for GOHIBIC (vilobelimab). Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC (vilobelimab) use.
GOHIBIC (vilobelimab) has been associated with an increase of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC (vilobelimab). Hypersensitivity reactions have been observed with GOHIBIC (vilobelimab). If a severe hypersensitivity reaction occurs, administration of GOHIBIC (vilobelimab) should be discontinued and appropriate therapy initiated.
The most common adverse reactions (incidence ≥
Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors, serious AEs or deaths that occur during GOHIBIC (vilobelimab) treatment and are considered to be potentially attributable to GOHIBIC (vilobelimab).
Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. In addition, side effects can be reported to InflaRx at: pvusa@inflarx.de.
For the full prescribing information and additional important safety information, please visit www.GOHIBIC.com.
About vilobelimab
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of free 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 free C5a as a key “amplifier” of this response.
About INF904
INF904 is an orally administered, small molecule inhibitor of the C5a receptor Ca5R1 that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has minimal inhibition of the cytochrome 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 to 90 mg twice per day for 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of INF904 with a ≥
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 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 is also developing INF904, an orally administered small molecule inhibitor of C5a-induced signaling via 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.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).
Contacts:
| InflaRx N.V. | MC Services AG |
| Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de | Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752 |
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals and related treatment recommendations by medical/healthcare institutes and other third-party organizations; our ability to successfully commercialize and the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indications or for vilobelimab and any other product candidates, under an EUA and in the future if approved for commercial use in the U.S. or elsewhere; our ability to successfully implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’s treatment of COVID-19 and other debilitating or life-threatening inflammatory indications, including PG, and any other product candidates, including INF904, 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 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 expectations regarding the scope of any approved indication for vilobelimab; our ability to leverage our proprietary anti-C5a and C5aR technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab 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 and 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.
FAQ
What were InflaRx (IFRX) key financial results for Q2 2025?
When will InflaRx report INF904 Phase 2a data for CSU and HS?
Why did InflaRx stop its Phase 3 pyoderma gangrenosum trial?
What is the status of GOHIBIC (vilobelimab) in Europe?
What were the results of Staidson's Phase 1/2 trial for BDB-001?
