InflaRx Reports Full Year 2024 Results and Highlights Key Achievements and Expected Milestones
InflaRx (IFRX) reported key achievements for 2024 and milestones for 2025. The company received European Commission approval for GOHIBIC® (vilobelimab) to treat SARS-CoV-2-induced ARDS. They reached a 30-patient recruitment milestone in Phase 3 vilobelimab trial for pyoderma gangrenosum, with interim analysis expected by May 2025.
Financial highlights include:
- Cash position of €55.2 million as of December 31, 2024
- Additional €28.7 million raised through public offering in February 2025
- Cash runway extended into 2027
- Net loss of €46.1 million (€0.78 per share) in 2024
- R&D expenses decreased to €35.4 million
The company dosed first patient in Phase 2a trial for oral C5aR inhibitor INF904, with topline data in chronic spontaneous urticaria and hidradenitis suppurativa expected in summer 2025. Multiple data presentations at AAD 2025 highlighted vilobelimab's potential in reducing systemic inflammation.
InflaRx (IFRX) ha riportato risultati chiave per il 2024 e traguardi per il 2025. L'azienda ha ricevuto l'approvazione della Commissione Europea per GOHIBIC® (vilobelimab) per trattare l'ARDS indotto da SARS-CoV-2. Hanno raggiunto un traguardo di reclutamento di 30 pazienti nella sperimentazione di fase 3 del vilobelimab per il gangrenoso pyoderma, con un'analisi intermedia prevista per maggio 2025.
I punti salienti finanziari includono:
- Posizione di liquidità di €55,2 milioni al 31 dicembre 2024
- Ulteriori €28,7 milioni raccolti attraverso un'offerta pubblica a febbraio 2025
- Liquidità estesa fino al 2027
- Perdita netta di €46,1 milioni (€0,78 per azione) nel 2024
- Spese per R&S ridotte a €35,4 milioni
L'azienda ha somministrato il primo paziente nella sperimentazione di fase 2a per l'inibitore orale C5aR INF904, con dati preliminari su orticaria cronica spontanea e hidradenite suppurativa attesi per l'estate 2025. Diverse presentazioni di dati all'AAD 2025 hanno evidenziato il potenziale del vilobelimab nella riduzione dell'infiammazione sistemica.
InflaRx (IFRX) informó sobre logros clave para 2024 y hitos para 2025. La empresa recibió la aprobación de la Comisión Europea para GOHIBIC® (vilobelimab) para tratar el ARDS inducido por SARS-CoV-2. Alcanzaron un hito de reclutamiento de 30 pacientes en el ensayo de fase 3 del vilobelimab para el pioderma gangrenoso, con un análisis intermedio previsto para mayo de 2025.
Los aspectos financieros destacados incluyen:
- Posición de efectivo de €55,2 millones al 31 de diciembre de 2024
- €28,7 millones adicionales recaudados a través de una oferta pública en febrero de 2025
- Liquidez extendida hasta 2027
- Pérdida neta de €46,1 millones (€0,78 por acción) en 2024
- Gastos en I+D reducidos a €35,4 millones
La empresa administró el primer paciente en el ensayo de fase 2a para el inhibidor oral C5aR INF904, con datos preliminares sobre urticaria crónica espontánea e hidradenitis supurativa esperados para el verano de 2025. Múltiples presentaciones de datos en AAD 2025 destacaron el potencial del vilobelimab para reducir la inflamación sistémica.
InflaRx (IFRX)는 2024년 주요 성과와 2025년 이정표를 보고했습니다. 이 회사는 SARS-CoV-2로 유도된 ARDS 치료를 위한 GOHIBIC® (vilobelimab)에 대해 유럽연합 집행위원회의 승인을 받았습니다. 그들은 pyoderma gangrenosum에 대한 vilobelimab 3상 시험에서 30명의 환자 모집 이정표를 달성했으며, 중간 분석은 2025년 5월에 예정되어 있습니다.
재무 하이라이트는 다음과 같습니다:
- 2024년 12월 31일 기준 현금 보유액 €55.2 백만
- 2025년 2월 공개 모집을 통해 추가로 €28.7 백만을 모금
- 현금 유동성 2027년까지 연장
- 2024년 순손실 €46.1 백만 (€0.78 주당)
- R&D 비용이 €35.4 백만으로 감소
회사는 경구 C5aR 억제제 INF904의 2a상 시험에서 첫 번째 환자를 투여했으며, 만성 자발성 두드러기 및 hidradenitis suppurativa에 대한 주요 데이터는 2025년 여름에 예상됩니다. AAD 2025에서 여러 데이터 발표가 vilobelimab의 전신 염증 감소 가능성을 강조했습니다.
InflaRx (IFRX) a rapporté des réalisations clés pour 2024 et des jalons pour 2025. L'entreprise a obtenu l'approbation de la Commission européenne pour GOHIBIC® (vilobelimab) pour traiter l'ARDS induit par le SARS-CoV-2. Ils ont atteint un jalon de recrutement de 30 patients dans l'essai de phase 3 du vilobelimab pour le pyodermite gangreneuse, avec une analyse intermédiaire prévue pour mai 2025.
Les points forts financiers incluent :
- Position de trésorerie de 55,2 millions d'euros au 31 décembre 2024
- 28,7 millions d'euros supplémentaires levés par le biais d'une offre publique en février 2025
- Liquidité prolongée jusqu'en 2027
- Perte nette de 46,1 millions d'euros (0,78 € par action) en 2024
- Dépenses de R&D réduites à 35,4 millions d'euros
L'entreprise a administré le premier patient dans l'essai de phase 2a pour l'inhibiteur oral C5aR INF904, avec des données préliminaires sur l'urticaire chronique spontanée et l'hidradenite suppurative attendues pour l'été 2025. Plusieurs présentations de données lors de l'AAD 2025 ont mis en évidence le potentiel du vilobelimab à réduire l'inflammation systémique.
InflaRx (IFRX) berichtete über wichtige Erfolge für 2024 und Meilensteine für 2025. Das Unternehmen erhielt die Genehmigung der Europäischen Kommission für GOHIBIC® (vilobelimab) zur Behandlung von ARDS, das durch SARS-CoV-2 verursacht wird. Sie erreichten einen Rekrutierungsmeilenstein von 30 Patienten in der Phase-3-Studie zu vilobelimab bei pyodermatischer Gangrän, mit einer Zwischenanalyse, die für Mai 2025 erwartet wird.
Finanzielle Highlights umfassen:
- Liquiditätsposition von €55,2 Millionen zum 31. Dezember 2024
- Zusätzliche €28,7 Millionen durch eine öffentliche Angebot im Februar 2025 gesammelt
- Liquiditätslaufzeit bis 2027 verlängert
- Nettoverlust von €46,1 Millionen (€0,78 pro Aktie) im Jahr 2024
- F&E-Ausgaben auf €35,4 Millionen gesenkt
Das Unternehmen verabreichte den ersten Patienten in der Phase-2a-Studie für den oralen C5aR-Inhibitor INF904, wobei die Hauptdaten zu chronischer spontaner Urtikaria und Hidradenitis suppurativa im Sommer 2025 erwartet werden. Mehrere Datenpräsentationen auf dem AAD 2025 hoben das Potenzial von vilobelimab zur Reduzierung systemischer Entzündungen hervor.
- European Commission approval for GOHIBIC® (vilobelimab) for SARS-CoV-2-induced ARDS
- Successful €28.7M fundraising through public offering
- Cash runway extended into 2027
- R&D expenses decreased by €5.7M to €35.4M
- Potential €1B+ market opportunity for each indication (CSU and HS) with INF904
- Net loss increased to €46.1M in 2024 from €42.7M in 2023
- Marketing and sales expenses increased by €2.8M
- Cost of sales increased by €2.8M due to inventory write-downs
- Low product revenue of only €0.2M from GOHIBIC sales
Insights
InflaRx's year-end results reveal a strategic advancement phase with significant regulatory success and pipeline progression, despite widening losses. The EU approval for GOHIBIC (vilobelimab) represents their first marketed product in Europe for SARS-CoV-2-induced ARDS, creating potential future revenue streams, though commercialization partnerships would be needed to realize this potential.
The company's financial position shows strengthening, with €55.2 million in cash at year-end, bolstered by an additional €28.7 million raised in February 2025. This extends their runway into 2027, providing critical operational stability through multiple clinical readouts. However, the €46.1 million net loss (versus €42.7 million in 2023) highlights ongoing cash burn challenges typical for clinical-stage biotechs.
Two key catalysts warrant investor attention: the upcoming interim analysis for the Phase 3 vilobelimab PG trial expected by May 2025, and summer 2025 topline data from the Phase 2a trial of oral C5aR inhibitor INF904 in CSU and HS. Both represent potential inflection points, particularly as the company estimates these indications could each represent addressable markets exceeding $1 billion.
R&D expense reduction to €35.4 million (down €5.7 million) demonstrates improved operational efficiency, though increased marketing expenses of €2.8 million and inventory write-downs of €2.8 million partially offset these gains. Current product revenue remains minimal at just €0.2 million, emphasizing that InflaRx remains primarily a development-stage company despite having approved products.
InflaRx's complement pathway inhibitor portfolio shows promising clinical development momentum. The European Commission approval for GOHIBIC (vilobelimab) marks a significant regulatory achievement as the first approved treatment for SARS-CoV-2-induced ARDS in the EU. This validates their C5a inhibition approach while creating a template for potential future approvals.
Their pyoderma gangrenosum (PG) program has reached a critical juncture with the 30-patient recruitment milestone enabling an interim analysis by May 2025. This adaptive trial design is strategically sound for a rare disease indication, allowing for sample size adjustments based on observed treatment effects, potentially accelerating development timelines while controlling costs.
The oral C5aR inhibitor INF904 represents InflaRx's next-generation approach, with potential advantages in dosing convenience and possibly differentiated efficacy. The Phase 2a basket trial design in CSU and HS is efficient, examining both safety/PK and preliminary efficacy signals simultaneously across multiple indications. The 4-week treatment period should provide sufficient data to inform future development, though longer treatment duration would be needed to fully assess chronic treatment potential.
Multiple AAD presentations highlighting vilobelimab's potential in reducing systemic inflammation reinforce the broader applicability of their complement inhibition platform. The selection by BARDA for inclusion in their ARDS platform study provides additional validation and potential for expanded indications beyond COVID-19, supporting the company's scientific approach and potentially broadening future market opportunities.
- Received European Commission approval for GOHIBIC® (vilobelimab) for the treatment of SARS-CoV-2-induced acute respiratory distress syndrome (ARDS)
- Achieved 30-patient recruitment milestone in Phase 3 vilobelimab trial in pyoderma gangrenosum (PG) to enable an expected interim analysis for trial size adaptation or futility by the end of May 2025
- Dosed first patient in Phase 2a trial for oral C5aR inhibitor, INF904, with topline data in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) expected in summer 2025
- Multiple data presentations at AAD 2025 highlighting the potential of vilobelimab in reducing systemic inflammation
- Cash, cash equivalents and marketable securities of
€55.2 million as of December 31, 2024 - Additional
€28.7 million ($30.0 million ) in gross proceeds subsequently raised by an underwritten public offering of ordinary shares and pre-funded warrants on February 18, 2025 - InflaRx’s cash runway significantly extended, with sufficient cash, cash equivalents and marketable securities to fund currently planned operations into 2027
JENA, Germany, March 20, 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 year ended December 31, 2024, highlighting recent operational achievements and expected milestones for 2025.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “2024 was a highly productive year for InflaRx, with the company achieving all major development and regulatory goals across its pipeline programs and making meaningful progress in addressing critical medical needs in inflammatory diseases.” He continued: “We look forward to a catalyst-rich year in 2025 as we continue to advance our pipeline, including reaching the interim analysis for the Phase 3 trial with vilobelimab in pyoderma gangrenosum and reporting top-line Phase 2a data in chronic spontaneous urticaria and hidradenitis suppurativa with INF904, our oral C5aR inhibitor with best-in-class potential."
Select recent highlights and expected milestones
INF904 in CSU and HS – Topline Phase 2a data expected in summer 2025
In December 2024, InflaRx announced that the first patient had been dosed in its Phase 2a basket study with INF904 in CSU and HS. This is a multi-center, open-label study evaluating multiple INF904 dosing regimens over 4 weeks of treatment in a total of 75 patients (45 in CSU and 30 in HS). The goal of the trial is to generate additional safety and pharmacokinetic (PK) data and to provide signs of clinical benefit. After the 4-week treatment period, patients will be followed for an additional 4 weeks. Topline data from this study are expected in the summer of 2025, with a goal of informing the planning and design of a larger, longer-term Phase 2b study by year-end 2025.
InflaRx believes CSU and HS each has potential addressable markets of
Vilobelimab in PG – Pivotal Phase 3 trial interim analysis expected by the end of May 2025
In November 2024, InflaRx announced that it had achieved the 30-patient recruitment milestone in its ongoing Phase 3 vilobelimab trial in PG. This is expected to enable the interim analysis for trial size adaptation or futility by the end of May 2025. Trial enrollment continues. The study dosed its first patient in November 2023 and has an adaptive design with an interim analysis (unblinded only for the independent data monitoring committee), which is planned when 30 patients randomized 1:1 to the two arms have completed treatment. The interim analysis with a set of predefined rules will consider the then-observed difference in complete target ulcer closure between the two arms and will then determine whether the trial sample size will be adapted or whether the trial should be stopped due to futility. The enrollment period is projected to last at least two years, and its overall period will depend on the total trial size after sample size adaptation.
The Phase 3 trial is a multi-national, randomized, double-blind, placebo-controlled pivotal study assessing the benefit of vilobelimab for treating ulcerative PG, a rare, chronic inflammatory form of neutrophilic dermatosis characterized by accumulation of neutrophils in the affected skin areas. The trial has two arms: (1) vilobelimab plus a low dose of corticosteroids and (2) placebo plus the same dose of corticosteroids, both tapered over an 8-week period. The primary endpoint of the study is complete closure of the target ulcer measured at two consecutive visits at any time up to 26 weeks after initiation of treatment.
Vilobelimab has been granted orphan drug designation for the treatment of PG by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as fast track designation by the FDA.
Vilobelimab presentations at the 2025 AAD Annual Meeting
During the 2025 American Academy of Dermatology (AAD) Annual Meeting held March 7 – 11 in Orlando, FL, vilobelimab was featured in multiple sessions. Collectively, these data highlighted the utility of vilobelimab in treating multiple inflammatory conditions, including PG and HS, with supporting evidence from clinical efficacy data, safety assessments, and pharmacokinetic and pharmacodynamic analyses.
GOHIBIC (vilobelimab) granted EU marketing authorization
In January 2025, the European Commission (EC) granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced ARDS who are receiving systemic corticosteroids as part of standard of 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 European Union (EU) for the treatment of SARS-CoV-2-induced ARDS.
The marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway. InflaRx is considering commercial partnering and distribution options in the EU and does not expect this approach will have a materially negative impact on its cash burn rate.
In June 2024, InflaRx announced that GOHIBIC (vilobelimab) had been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as one of three investigational therapies to be assessed in a Phase 2 clinical platform study exploring potential new options for the treatment of ARDS. Vilobelimab is one of three host-directed investigational drugs assessed in this study, with the safety and efficacy of each investigational drug to be studied in its own patient cohort and compared against placebo. This Phase 2 platform study is expected to collect data in order to define subsets of patients with ARDS who may benefit from specific host-directed therapeutics and to inform the design of potential Phase 3 studies.
Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “With our recent successful capital raise and the efficient utilization of our balance sheet, InflaRx is on solid financial footing, enabling us to efficiently advance our key development programs. Importantly, our cash runway into 2027 should allow us to reach several value inflection points, including the end-of-May interim analysis for the vilobelimab Phase 3 study in pyoderma gangrenosum, along with the eventual readout of this trial, as well as the INF904 Phase 2a topline data this summer.”
Financing activities
In February 2025, the company completed an underwritten public offering of ordinary shares and pre-funded warrants leading to gross proceeds from the offering of
2024 Financial highlights
Revenue
In 2024, we realized revenues from product sales of GOHIBIC (vilobelimab) in the amount of
Cost of sales
Cost of sales increased by
Marketing and sales expenses
Marketing and sales expenses increased by
Research and development expenses
Research and development expenses decreased by
General and administrative expenses
General and administrative expenses increased by
Other income
Other income decreased by
Net financial result
Net financial result increased by
Net loss
We incurred a net loss of
Liquidity and capital resources
As of December 31, 2024, our total funds available amounted to approximately
Net cash used in operating activities
Net cash used in operating activities increased to
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 today with the U.S. Securities and Exchange Commission (SEC).
InflaRx N.V. and subsidiaries
Consolidated statements of operations and comprehensive loss
for the years ended December 31, 2024, 2023 and 2022
2024 | 2023 | 2022 | |||||||
(in €, except for share data) | |||||||||
Revenues | 165,789 | 63,089 | — | ||||||
Cost of sales | (3,317,039 | ) | (532,262 | ) | — | ||||
Gross profit | (3,151,250 | ) | (469,173 | ) | — | ||||
Marketing and sales expenses | (6,756,595 | ) | (4,001,299 | ) | — | ||||
Research and development expenses | (35,363,897 | ) | (41,024,131 | ) | (37,526,090 | ) | |||
General and administrative expenses | (13,024,441 | ) | (12,628,756 | ) | (14,869,564 | ) | |||
Other income | 5,287,616 | 13,219,704 | 20,159,169 | ||||||
Other expenses | (297 | ) | (4,440 | ) | (1,381 | ) | |||
Operating result | (53,008,864 | ) | (44,908,096 | ) | (32,237,866 | ) | |||
Finance income | 3,196,813 | 3,804,827 | 608,679 | ||||||
Finance expenses | (20,655 | ) | (35,628 | ) | (45,250 | ) | |||
Foreign exchange result | 3,670,235 | (1,841,872 | ) | 2,442,297 | |||||
Other financial result | 103,285 | 313,240 | (252,471 | ) | |||||
Income taxes | (5,217 | ) | — | — | |||||
Loss for the period | (46,064,402 | ) | (42,667,529 | ) | (29,484,611 | ) | |||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | |||||||||
Exchange differences on translation of foreign currency | 58,344 | 125,085 | 4,206,810 | ||||||
TOTAL COMPREHENSIVE LOSS | (46,006,058 | ) | (42,542,444 | ) | (25,277,801 | ) | |||
Share information | |||||||||
Weighted average number of shares outstanding | 58,918,678 | 54,940,137 | 44,207,873 | ||||||
Loss per share (basic/diluted) | (0.78 | ) | (0.78 | ) | (0.67 | ) | |||
InflaRx N.V. and subsidiaries
Consolidated statements of financial position as of December 31, 2024 and 2023
December 31, 2024 | December 31, 2023 | |||||
ASSETS | (in €) | |||||
Non-current assets | ||||||
Property and equipment | 256,280 | 289,577 | ||||
Right-of-use assets | 758,368 | 1,071,666 | ||||
Intangible assets | 50,781 | 68,818 | ||||
Other assets | 204,233 | 257,267 | ||||
Financial assets | 3,092,290 | 9,052,741 | ||||
Total non-current assets | 4,361,952 | 10,740,069 | ||||
Current assets | ||||||
Inventories | 6,897,666 | 11,367,807 | ||||
Current other assets | 5,103,402 | 4,036,649 | ||||
Other assets from government grants and research allowance | 5,081,772 | — | ||||
Tax receivable | 1,735,335 | 3,791,564 | ||||
Other financial assets | 34,462,352 | 77,504,518 | ||||
Cash and cash equivalents | 18,375,979 | 12,767,943 | ||||
Total current assets | 71,656,505 | 109,468,482 | ||||
TOTAL ASSETS | 76,018,457 | 120,208,551 | ||||
EQUITY AND LIABILITIES | ||||||
Equity | ||||||
Issued capital | 7,122,205 | 7,065,993 | ||||
Share premium | 334,929,685 | 334,211,338 | ||||
Other capital reserves | 44,115,861 | 40,050,053 | ||||
Accumulated deficit | (332,192,221 | ) | (286,127,819 | ) | ||
Other components of equity | 7,440,510 | 7,382,166 | ||||
Total equity | 61,416,039 | 102,581,730 | ||||
Non-current liabilities | ||||||
Lease liabilities | 399,066 | 745,716 | ||||
Other liabilities | 36,877 | 36,877 | ||||
Total non-current liabilities | 435,943 | 782,593 | ||||
Current liabilities | ||||||
Trade and other payables | 11,394,232 | 11,974,362 | ||||
Lease liabilities | 406,020 | 374,329 | ||||
Employee benefits | 2,064,678 | 1,609,766 | ||||
Other liabilities | 301,544 | 2,885,772 | ||||
Total current liabilities | 14,166,475 | 16,844,228 | ||||
Total liabilities | 14,602,417 | 17,626,822 | ||||
TOTAL EQUITY AND LIABILITIES | 76,018,457 | 120,208,552 |
InflaRx N.V. and subsidiaries
Consolidated statements of changes in shareholders’ equity
for the years ended December 31, 2024, 2023 and 2022
in € | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other components of equity | Total equity | ||||||||
Balance as of January 01, 2022 | 5,304,452 | 280,310,744 | 30,591,209 | (213,975,679 | ) | 3,050,270 | 105,280,996 | |||||||
Loss for the Period | — | — | — | (29,484,611 | ) | — | (29,484,611 | ) | ||||||
Exchange differences on translation of foreign currency | — | — | — | — | 4,206,810 | 4,206,810 | ||||||||
Total Comprehensive Loss | — | — | — | (29,484,611 | ) | 4,206,810 | (25,277,801 | ) | ||||||
Issuance of ordinary shares | 60,000 | 2,289,624 | — | — | — | 2,349,624 | ||||||||
Transaction costs | — | (47,735 | ) | — | — | — | (47,735 | ) | ||||||
Equity-settled share-based payments | — | — | 6,044,356 | — | — | 6,044,356 | ||||||||
Balance as of December 31, 2022 | 5,364,452 | 282,552,633 | 36,635,564 | (243,460,290 | ) | 7,257,080 | 88,349,440 | |||||||
Loss for the Period | — | — | — | (42,667,529 | ) | — | (42,667,529 | ) | ||||||
Exchange differences on translation of foreign currency | — | — | — | — | 125,085 | 125,085 | ||||||||
Total Comprehensive Loss | — | — | — | (42,667,529 | ) | 125,085 | (42,542,444 | ) | ||||||
Issuance of ordinary shares | 1,687,110 | 54,796,819 | — | — | — | 56,483,929 | ||||||||
Transaction costs | — | (3,360,626 | ) | — | — | — | (3,360,626 | ) | ||||||
Equity-settled share-based payments | — | — | 3,414,489 | — | — | 3,414,489 | ||||||||
Share options exercised | 14,431 | 222,512 | — | — | — | 236,943 | ||||||||
Balance as of December 31, 2023 | 7,065,993 | 334,211,338 | 40,050,053 | (286,127,819 | ) | 7,382,166 | 102,581,730 | |||||||
Loss for the Period | — | — | — | (46,064,402 | ) | — | (46,064,402 | ) | ||||||
Exchange differences on translation of foreign currency | — | — | — | — | 58,344 | 58,344 | ||||||||
Total Comprehensive Loss | — | — | — | (46,064,402 | ) | 58,344 | (46,006,058 | ) | ||||||
Issuance of ordinary shares | 56,213 | 1,042,076 | — | — | — | 1,098,289 | ||||||||
Transaction costs | — | (323,729 | ) | — | — | — | (323,729 | ) | ||||||
Equity-settled share-based payments | — | — | 4,065,807 | — | — | 4,065,807 | ||||||||
Balance as of December 31, 2024 | 7,062,206 | 334,929,685 | 44,115,861 | (332,192,221 | ) | 7,440,510 | 61,416,039 | |||||||
InflaRx N.V. and subsidiaries
Consolidated statements of cash flows
for the years ended December 31, 2024, 2023 and 2022
2024 | 2023 | 2022 | |||||||
(in €) | |||||||||
Operating activities | |||||||||
Loss for the period | (46,064,402 | ) | (42,667,529 | ) | (29,484,611 | ) | |||
Adjustments for: | |||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | 485,114 | 567,780 | 596,597 | ||||||
Net finance income | (6,949,679 | ) | (2,240,566 | ) | (2,753,255 | ) | |||
Share-based payment expense | 4,065,807 | 3,414,489 | 6,044,356 | ||||||
Net foreign exchange differences | (37,101 | ) | 413,017 | 385,359 | |||||
Changes in: | |||||||||
Other assets from government grants and research allowances | (5,081,772 | ) | 732,971 | (732,971 | ) | ||||
Other assets | 1,042,513 | 7,825,181 | (3,308,485 | ) | |||||
Employee benefits | 454,912 | 297,518 | (64,024 | ) | |||||
Other liabilities | (2,584,228 | ) | 2,738,164 | 9,403 | |||||
Liabilities from government grants received | — | (6,209,266 | ) | (2,090,734 | ) | ||||
Trade and other payables | (580,129 | ) | 6,986,824 | (3,586,706 | ) | ||||
Inventories | 4,470,141 | (11,367,807 | ) | — | |||||
Interest received | 2,243,197 | 1,732,284 | 1,287,200 | ||||||
Interest paid | (21,064 | ) | (36,025 | ) | (44,946 | ) | |||
Net cash used in operating activities | (48,556,690 | ) | (37,812,966 | ) | (33,742,817 | ) | |||
Investing activities | |||||||||
Purchase of intangible assets and property and equipment | (46,871 | ) | (81,100 | ) | (162,391 | ) | |||
Purchase of current and non-current financial assets | (35,340,107 | ) | (104,051,972 | ) | (64,474,543 | ) | |||
Proceeds from the maturity of current financial assets | 87,751,331 | 86,436,456 | 83,995,029 | ||||||
Net cash from/ (used in) investing activities | 52,364,354 | (17,696,616 | ) | 19,358,095 | |||||
Financing activities | |||||||||
Proceeds from issuance of ordinary shares | 1,098,289 | 56,483,929 | 2,349,624 | ||||||
Transaction costs from issuance of ordinary shares | (323,729 | ) | (3,360,626 | ) | (47,735 | ) | |||
Proceeds from exercise of share options | — | 236,943 | — | ||||||
Repayment of lease liabilities | (388,114 | ) | (373,977 | ) | (364,430 | ) | |||
Net cash from financing activities | 386,446 | 52,986,269 | 1,937,459 | ||||||
Net in-/decrease in cash and cash equivalents | 4,194,110 | (2,523,313 | ) | (12,447,262 | ) | ||||
Effect of exchange rate changes on cash and cash equivalents | 1,413,926 | (974,099 | ) | 2,462,622 | |||||
Cash and cash equivalents at beginning of period | 12,767,943 | 16,265,355 | 26,249,995 | ||||||
Cash and cash equivalents at end of period | 18,375,979 | 12,767,943 | 16,265,355 |
About GOHIBIC (vilobelimab)
In the EU, GOHIBIC (vilobelimab) has been granted 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 invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (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 EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS.
In the U.S., GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving IMV or ECMO. 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 (vilobelimab) website http://www.gohibic.com.
Important Safety Information about GOHIBIC (vilobelimab)
There are 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 and 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.
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.
About 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.
Vilobelimab is being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (PG). Vilobelimab has been granted orphan drug designation for the treatment of PG by both the FDA and the EMA, as well as fast track designation by the FDA.
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 the best-in-class potential of INF904 with a ≥
About InflaRx N.V.
InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, 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 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.
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 |
* Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions provided on the webpage: The InflaRx Commitment Program.
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.
