InflaRx Reports Third Quarter 2024 Financial Results and Provides Business Update
InflaRx reported Q3 2024 financial results and business updates. Key developments include reaching a 30-patient recruitment milestone in Phase 3 vilobelimab trial for pyoderma gangrenosum, with interim analysis expected by end of Q2 2025. The company plans to initiate a Phase 2a trial for INF904 by year-end 2024, with first data readout expected in summer 2025. Cash position stands at €62.0 million, expected to fund operations into 2026. Revenue from GOHIBIC sales was €166 thousand, with net loss increasing to €41.0 million for the first nine months of 2024 compared to €26.7 million in the same period of 2023.
InflaRx ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. I principali sviluppi includono il raggiungimento di un traguardo di reclutamento di 30 pazienti nello studio di Fase 3 del vilobelimab per la pioderma gangrenoso, con un'analisi intermedia prevista entro la fine del secondo trimestre 2025. L'azienda prevede di avviare uno studio di Fase 2a per INF904 entro la fine del 2024, con il primo resoconto dei dati previsto per l'estate 2025. La posizione di cassa è di 62,0 milioni di euro, previsto per finanziare le operazioni fino al 2026. I ricavi dalle vendite di GOHIBIC ammontano a 166 mila euro, con una perdita netta che aumenta a 41,0 milioni di euro per i primi nove mesi del 2024 rispetto ai 26,7 milioni di euro nello stesso periodo del 2023.
InflaRx informó los resultados financieros del tercer trimestre de 2024 y actualizaciones empresariales. Los desarrollos clave incluyen el logro de un hito de reclutamiento de 30 pacientes en el ensayo de Fase 3 del vilobelimab para el pioderma gangrenoso, con un análisis intermedio esperado para finales del segundo trimestre de 2025. La compañía planea iniciar un ensayo de Fase 2a para INF904 antes de que finalice 2024, con la primera lectura de datos esperada para el verano de 2025. La posición de efectivo se sitúa en 62,0 millones de euros, previsto para financiar las operaciones hasta 2026. Los ingresos por ventas de GOHIBIC fueron de 166 mil euros, con una pérdida neta que aumentó a 41,0 millones de euros durante los primeros nueve meses de 2024 en comparación con 26,7 millones de euros en el mismo período de 2023.
InflaRx는 2024년 3분기 재무 결과 및 사업 업데이트를 보고했습니다. 주요 발전 사항에는 vilobelimab의 3상 시험에서 30명의 환자 모집 이정표를 도달한 것이 포함되며, 중간 분석은 2025년 2분기 말까지 예상됩니다. 회사는 2024년 말까지 INF904의 2a상 시험을 시작할 계획이며, 첫 데이터 분석은 2025년 여름으로 예상됩니다. 현금 보유량은 6200만 유로이며, 2026년까지 운영 자금을 지원할 것으로 예상됩니다. GOHIBIC 판매로 인한 수익은 16만6천 유로였으며, 2024년 첫 9개월 동안 순손실은 4천1백만 유로로 증가했으며, 이는 2023년 같은 기간의 2천6백70만 유로와 비교됩니다.
InflaRx a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour sur l'activité. Les développements clés incluent l'atteinte d'un objectif de recrutement de 30 patients dans l'essai de Phase 3 du vilobelimab pour le pyoderm gangrenux, avec une analyse intermédiaire attendue d'ici la fin du deuxième trimestre 2025. La société prévoit de lancer un essai de Phase 2a pour INF904 d'ici la fin de 2024, avec une première lecture des données attendue pour l'été 2025. La position de trésorerie s'élève à 62,0 millions d'euros, censée financer les opérations jusqu'en 2026. Les revenus provenant des ventes de GOHIBIC s'élèvent à 166 000 euros, la perte nette augmentant à 41,0 millions d'euros pour les neuf premiers mois de 2024 par rapport à 26,7 millions d'euros durant la même période de 2023.
InflaRx berichtete über die finanziellen Ergebnisse des 3. Quartals 2024 und Unternehmensaktualisierungen. Zu den wichtigsten Entwicklungen gehört das Erreichen eines Rekrutierungsmeilensteins von 30 Patienten in der Phase-3-Studie des vilobelimab für pyoderm gangrenosum, mit einer vorläufigen Analyse, die bis Ende Q2 2025 erwartet wird. Das Unternehmen plant, bis Ende 2024 eine Phase-2a-Studie für INF904 zu starten, wobei die erste Datenauswertung im Sommer 2025 erwartet wird. Die liquide Mittel betragen 62,0 Millionen Euro, die voraussichtlich die Operationen bis 2026 finanzieren werden. Die Einnahmen aus dem Verkauf von GOHIBIC betrugen 166 Tausend Euro, wobei der Nettverlust in den ersten neun Monaten 2024 auf 41,0 Millionen Euro anstieg, verglichen mit 26,7 Millionen Euro im gleichen Zeitraum 2023.
- Strong cash position of €62.0 million, funding operations into 2026
- Achievement of 30-patient recruitment milestone in Phase 3 vilobelimab trial
- Initial revenue generation from GOHIBIC product sales
- Net loss increased to €41.0 million from €26.7 million year-over-year
- Sales and marketing expenses increased by €3.2 million compared to previous year
- Decrease in other income by €13.2 million due to end of government grant support
Insights
The Q3 2024 results reveal a challenging financial position for InflaRx. Key metrics show
The cash position of
The pipeline progress, particularly with vilobelimab and INF904, could drive value, but near-term catalysts are to mid-2025. The company's focus on cost management while advancing key programs shows prudent financial strategy, though significant revenue growth appears distant.
The development pipeline shows strategic positioning in high-value indications. The Phase 3 vilobelimab trial in pyoderma gangrenosum reaching its 30-patient milestone for interim analysis is significant, with results expected by Q2 2025. The upcoming Phase 2a trial for INF904 in chronic spontaneous urticaria and hidradenitis suppurativa targets markets potentially worth
The CHMP review of vilobelimab for COVID-19 ARDS could provide near-term validation, with an opinion expected mid-November. However, commercialization impact may be given current COVID-19 trends. The company's focus on immuno-dermatology indications represents a more sustainable long-term strategy.
- Achieved 30-patient recruitment milestone in Phase 3 vilobelimab trial in pyoderma gangrenosum (PG) to enable interim analysis, with guidance for trial size adaptation or futility expected by the end of 2Q 2025
- InflaRx pipeline highlighted at multiple medical congresses, including vilobelimab in COVID-19 and hidradenitis suppurativa (HS) and INF904
- Phase 2a trial for INF904 expected to initiate by year-end 2024, with first data readout expected in summer 2025
- European Committee for Medicinal Products for Human Use (CHMP) review of vilobelimab continues, with discussions ongoing and a CHMP opinion anticipated around mid-November
- Cash, cash equivalents and marketable securities of
€62.0 million , expected to fund operations into 2026
JENA, Germany, Nov. 08, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced financial results for the three and nine months ended September 30, 2024, and provided an operating update.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented:
“The start of the second half of 2024 has been a time of considerable momentum for the Company, and our leadership position in complement inhibition continues to strengthen. As we consider the remainder of the year, we remain well positioned to start our Phase 2a trial in two immuno-dermatology indications with INF904. We are excited about upcoming expected milestones looking into 2025, including the interim analysis of the vilobelimab Phase 3 trial in pyoderma gangrenosum and the first Phase 2a data readout from INF904.”
Guggenheim Securities Inaugural Healthcare Innovation Conference on November
11 - 13, 2024
InflaRx will participate in the Guggenheim Securities Inaugural Healthcare Innovation Conference on November 11, 2024, at 11:00 AM ET / 5:00 PM CET. A link to register for the fireside chat live stream and its replay is available here.
RECENT HIGHLIGHTS AND BUSINESS UPDATE
Oral C5aR inhibitor INF904
In March 2024, InflaRx announced it will pursue two initial immuno-dermatology indications with INF904 in a single Phase 2a basket trial that is expected to begin by the end of 2024, with initial data anticipated in summer 2025. The trial will be a multi-center, open-label study involving 75 patients and evaluating multiple INF904 dosing regimens over 4 weeks of treatment in patients with moderate-to-severe chronic spontaneous urticaria (CSU) and moderate-to-severe HS, both highly debilitating skin conditions. The objective of this Phase 2a trial is to generate additional safety and pharmacokinetic (PK) data and provide signs of clinical benefit, and to inform the design of a Phase 2b trial that InflaRx has a goal to initiate in late 2025.
InflaRx believes CSU and HS both have potential addressable markets of
New preclinical findings for INF904 presented at the 19th European Meeting on Complement in Human Diseases (EMCHD)
InflaRx presented two posters on INF904 at the EMCHD. InflaRx believes the collective data presented provided strong evidence of INF904’s significant anti-inflammatory and strong PK properties, further supporting the Company's belief that INF904 may have differentiating advantages and best-in-class potential as a member of the C5aR inhibitor drug class.
Vilobelimab in PG – Pivotal Phase 3 trial interim analysis expected by the end of 2Q 2025
Given recent progress in enrollment, InflaRx expects the results of the interim analysis for its ongoing Phase 3 trial of vilobelimab in PG in the second quarter of 2025. The study dosed its first patient in November 2023 and has an adaptive design with an interim analysis blinded for the sponsor and investigators (but unblinded for the independent data safety monitoring committee), which is planned when approximately 30 patients randomized 1:1 to the two arms have completed treatment. The interim analysis with a set of predefined rules will take into account 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 tapered over an 8-week period and (2) placebo plus the same dose of corticosteroids. The primary endpoint of the study is complete closure of the target ulcer 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 Marketing Authorization Application (MAA) in the European Union (EU)
In July 2023, InflaRx submitted an MAA for SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) to EMA. In October 2024, the Committee for Medicinal Products for Human Use (CHMP) convened to review the MAA; the regulatory process continues with discussions ongoing between the Company and the CHMP, with a CHMP opinion anticipated around the middle of November.
Should vilobelimab be approved in the EU, InflaRx is weighing options for its commercialization, with an expectation that efforts associated with any potential commercialization will not have a meaningfully negative impact on the Company’s cash burn.
GOHIBIC (vilobelimab) medical education program
During the second half of 2024, InflaRx continued its medical education efforts for GOHIBIC (vilobelimab) in COVID-19, with data presentations at multiple congresses in the U.S. and Asia. This included the 20th Annual Congress of International Drug Discovery Science & Technology, CHEST 2024, AMCP Nexus 2024, and ID Week. In addition, InflaRx presented a post hoc analysis of the SHINE trial of vilobelimab in HS at the 2024 European Academy of Dermatology and Venereology Congress.
Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “We continue to focus on efficiently utilizing our resources to advance our pipeline of complement inhibitors, with preparations to initiate a Phase 2a trial for INF904 and our continued progress with the ongoing late-stage trial of vilobelimab. InflaRx remains funded into 2026, and we look forward to reaching our next value inflection points.”
FINANCIAL HIGHLIGHTS
Revenue
For the nine months ended September 30, 2024, the Company realized revenues from product sales of GOHIBIC (vilobelimab) in the amount of
Cost of sales
Cost of sales during the nine months ended September 30, 2024 primarily consisted of write-downs of short-lived inventories.
Sales and marketing expenses
Sales and marketing expenses incurred for the nine months ended September 30, 2024 increased by
R&D expenses
R&D expenses incurred for the nine months ended September 30, 2024 decreased by
General and administrative expenses
General and administrative expenses decreased by
Other income
Other income for the nine months ended September 30, 2024 amounted to
Net financial result
Net financial result decreased by
Net loss
Net loss for the first nine months of 2024 amounted to
Net cash used in operating activities
Net cash used in operating activities for the first nine months of 2024 increased to
Liquidity and capital resources
As of September 30, 2024, InflaRx’s total available funds amounted to
From the
Additional financial information
Additional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of September 30, 2024, as well as the consolidated financial statements as of and for the year ended December 31, 2023, in “ITEM 18. Financial Statements,” in InflaRx’s annual report on Form 20-F for the year ended December 31, 2023, as filed with the U.S. Securities and Exchange Commission (SEC) on March 21, 2024.
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023
For the three months ended September 30, | For the nine months ended September 30 | ||||||||||||||
2024 (unaudited) | 2023 (unaudited) | 2024 (unaudited) | 2023 (unaudited) | ||||||||||||
(in €, except for share data) | |||||||||||||||
Revenues | 123,819 | 60,803 | 166,212 | 60,803 | |||||||||||
Cost of sales | 72,555 | (255,116 | ) | (496,119 | ) | (255,116 | ) | ||||||||
Gross profit (loss) | 196,374 | (194,313 | ) | (329,907 | ) | (194,313 | ) | ||||||||
Sales and marketing expenses | (1,707,748 | ) | (1,562,473 | ) | (4,995,915 | ) | (1,838,524 | ) | |||||||
Research and development expenses | (11,140,152 | ) | (7,305,541 | ) | (28,458,832 | ) | (32,957,044 | ) | |||||||
General and administrative expenses | (2,809,032 | ) | (2,897,732 | ) | (9,614,281 | ) | (10,047,091 | ) | |||||||
Other income | 101,108 | 808,866 | 153,839 | 13,437,963 | |||||||||||
Other expenses | (589 | ) | 339 | (297 | ) | (2,851 | ) | ||||||||
Operating result | (15,360,039 | ) | (11,150,854 | ) | (43,245,392 | ) | (31,601,861 | ) | |||||||
Finance income | 768,326 | 1,189,826 | 2,522,475 | 2,732,873 | |||||||||||
Finance expenses | (5,032 | ) | (4,897 | ) | (15,876 | ) | (15,476 | ) | |||||||
Foreign exchange result | (2,847,692 | ) | 2,292,938 | (311,905 | ) | 1,923,274 | |||||||||
Other financial result | — | 221,577 | 103,285 | 223,818 | |||||||||||
Income taxes | (5,217 | ) | — | (5,217 | ) | — | |||||||||
Income (loss) for the period | (17,449,654 | ) | (7,451,410 | ) | (40,952,630 | ) | (26,737,373 | ) | |||||||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | |||||||||||||||
Exchange differences on translation of foreign currency | (75,418 | ) | 73,574 | (72,582 | ) | 56,459 | |||||||||
Total comprehensive income (loss) | (17,525,072 | ) | (7,377,836 | ) | (41,025,212 | ) | (26,680,914 | ) | |||||||
Share information (based on income (loss) for the period) | |||||||||||||||
Weighted average number of shares outstanding | 58,883,272 | 58,883,272 | 58,883,272 | 53,598,594 | |||||||||||
Income (loss) per share (basic/diluted) | (0.30 | ) | (0.13 | ) | (0.70 | ) | (0.50 | ) | |||||||
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of financial position
as of September 30, 2024 and December 31, 2023
September 30, 2024 (unaudited) | December 31, 2023 | ||||||
(in €) | |||||||
ASSETS | |||||||
Non-current assets | |||||||
Property and equipment | 260,240 | 289,577 | |||||
Right-of-use assets | 850,001 | 1,071,666 | |||||
Intangible assets | 43,831 | 68,818 | |||||
Other assets | 217,491 | 257,267 | |||||
Financial assets | 4,694,199 | 9,052,741 | |||||
Total non-current assets | 6,065,762 | 10,740,069 | |||||
Current assets | |||||||
Inventories | 9,718,882 | 11,367,807 | |||||
Other assets | 3,714,912 | 4,036,650 | |||||
Trade receivables | 87,571 | — | |||||
Tax receivables | 2,211,455 | 3,791,564 | |||||
Financial assets | 31,683,244 | 77,504,518 | |||||
Cash and cash equivalents | 26,205,938 | 12,767,943 | |||||
Total current assets | 73,622,003 | 109,468,483 | |||||
TOTAL ASSETS | 79,687,764 | 120,208,552 | |||||
EQUITY AND LIABILITIES | |||||||
Equity | |||||||
Issued capital | 7,065,993 | 7,065,993 | |||||
Share premium | 334,211,338 | 334,211,338 | |||||
Other capital reserves | 43,775,960 | 40,050,053 | |||||
Accumulated deficit | (327,080,450 | ) | (286,127,819 | ) | |||
Other components of equity | 7,309,584 | 7,382,166 | |||||
Total equity | 65,282,425 | 102,581,730 | |||||
Non-current liabilities | |||||||
Lease liabilities | 498,928 | 745,716 | |||||
Other liabilities | 36,877 | 36,877 | |||||
Total non-current liabilities | 535,805 | 782,593 | |||||
Current liabilities | |||||||
Trade and other payables | 11,719,795 | 11,974,362 | |||||
Lease liabilities | 398,979 | 374,329 | |||||
Employee benefits | 1,514,478 | 1,609,766 | |||||
Other liabilities | 236,284 | 2,885,772 | |||||
Total current liabilities | 13,869,535 | 16,844,229 | |||||
Total Liabilities | 14,405,340 | 17,626,822 | |||||
TOTAL EQUITY AND LIABILITIES | 79,687,764 | 120,208,552 | |||||
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of changes in shareholders’ equity
for the nine months ended September 30, 2024 and 2023
(in €) | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other components of equity | Total equity | |||||||||||||||||
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 | — | — | — | (40,952,630 | ) | — | (40,952,630 | ) | |||||||||||||||
Exchange differences on translation of foreign currency | — | — | — | — | (72,582 | ) | (72,582 | ) | |||||||||||||||
Total comprehensive loss | — | — | — | (40,952,630 | ) | (72,582 | ) | (41,025,212 | ) | ||||||||||||||
Equity-settled share-based payments | — | — | 3,725,907 | — | — | 3,725,907 | |||||||||||||||||
Balance as of September 30, 2024 | 7,065,993 | 334,211,338 | 43,775,960 | (327,080,450 | ) | 7,309,584 | 65,282,425 | ||||||||||||||||
Balance as of January 1, 2023 | 5,364,452 | 282,552,633 | 36,635,564 | (243,460,290 | ) | 7,257,081 | 88,349,440 | ||||||||||||||||
Loss for the period | — | — | — | (26,737,373 | ) | — | (26,737,373 | ) | |||||||||||||||
Exchange differences on translation of foreign currency | — | — | — | — | 56,459 | 56,459 | |||||||||||||||||
Total comprehensive loss | — | — | — | (26,737,373 | ) | 56,459 | (26,680,914 | ) | |||||||||||||||
Issuance of common shares | 1,687,110 | 54,796,819 | — | — | — | 56,483,929 | |||||||||||||||||
Transaction costs | — | (3,360,626 | ) | — | — | — | (3,360,626 | ) | |||||||||||||||
Equity-settled share-based payments | — | — | 2,961,491 | — | — | 2,961,491 | |||||||||||||||||
Share options exercised | 14,431 | 222,512 | — | — | — | 236,943 | |||||||||||||||||
Balance as of September 30, 2023 | 7,065,993 | 334,211,338 | 39,597,055 | (270,197,663 | ) | 7,313,540 | 117,990,262 | ||||||||||||||||
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of cash flows
for the nine months ended September 30, 2024 and 2023
For the nine months ended September 30, | ||||||||||||
2024 (unaudited) | 2023 (unaudited) | |||||||||||
(in €) | ||||||||||||
Operating activities | ||||||||||||
Loss for the period | (40,952,630 | ) | (26,737,373 | ) | ||||||||
Adjustments for: | ||||||||||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | 374,377 | 432,248 | ||||||||||
Net finance income | (2,297,978 | ) | (4,864,488 | ) | ||||||||
Share-based payment expense | 3,725,907 | 2,961,491 | ||||||||||
Net foreign exchange differences | 10,930 | (82,574 | ) | |||||||||
Changes in: | ||||||||||||
Financial assets from government grants | (431,246 | ) | ||||||||||
Inventories | 1,648,925 | (1,639,490 | ) | |||||||||
Trade receivables | (87,571 | ) | — | |||||||||
Other assets | 1,941,622 | 4,468,239 | ||||||||||
Employee benefits | (95,288 | ) | (26,893 | ) | ||||||||
Other liabilities | (2,649,488 | ) | 2,893,461 | |||||||||
Liabilities from government grants received | (6,209,266 | ) | ||||||||||
Trade and other payables | (254,567 | ) | 1,011,662 | |||||||||
Income taxes paid | (5,217 | ) | — | |||||||||
Interest received | 1,990,054 | 1,302,391 | ||||||||||
Interest paid | (16,183 | ) | (15,773 | ) | ||||||||
Net cash used in operating activities | (36,661,890 | ) | (26,937,611 | ) | ||||||||
Investing activities | ||||||||||||
Purchase of intangible assets, property and equipment | (29,992 | ) | (45,942 | ) | ||||||||
Purchase of current financial assets | (27,835,062 | ) | (91,590,134 | ) | ||||||||
Proceeds from the maturity of financial assets | 78,273,017 | 71,113,455 | ||||||||||
Net cash from / (used in) investing activities | 50,407,963 | (20,522,621 | ) | |||||||||
Financing activities | ||||||||||||
Proceeds from issuance of common shares | — | 56,483,929 | ||||||||||
Transaction costs from issuance of common shares | — | (3,360,626 | ) | |||||||||
Proceeds from exercise of share options | — | 236,943 | ||||||||||
Repayment of lease liabilities | (290,145 | ) | (279,075 | ) | ||||||||
Net cash from / (used in) financing activities | (290,145 | ) | 53,081,170 | |||||||||
Net increase in cash and cash equivalents | 13,455,929 | 5,620,938 | ||||||||||
Effect of exchange rate changes on cash and cash equivalents | (17,934 | ) | (190,686 | ) | ||||||||
Cash and cash equivalents at beginning of period | 12,767,943 | 16,265,355 | ||||||||||
Cash and cash equivalents at end of period | 26,205,938 | 21,695,607 | ||||||||||
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 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 IMV or 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 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.
In addition to development in COVID-19, vilobelimab is also being developed for various debilitating or life-threatening inflammatory indications, including PG. Vilobelimab has been granted orphan drug designation for the treatment of PG by both the FDA and 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
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).
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, current expectations and the risks, uncertainties and other factors described under the headings, “Risk factors” and “Cautionary statement regarding forward looking statements“, in our periodic filings with the 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.
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