- Promising Phase 2a data announced for izicopan, underscoring its potential as a meaningfully differentiated, effective and safe oral inhibitor of C5aR
- Substantial progress made toward Phase 2b readiness for izicopan in hidradenitis suppurativa (HS)
- InflaRx actively reviewing and considering additional development in ANCA-associated vasculitis (AAV)
- To broaden izicopan signal-finding activities and expedite proof-of-concept studies into additional indications in inflammation and immunology (I&I), InflaRx intends to conduct a pharmacokinetic (PK) bridging study in
China this year - Active dialog with potential collaborators to expedite the Company’s total pipeline development goals continues
- InflaRx to host a virtual Capital Markets Day this spring to detail the expected clinical development path for izicopan in HS and to highlight its potential in HS, AAV and select additional I&I indications
- Cash, cash equivalents and marketable securities totaled €46.2 million on
December 31, 2025 , expected to fund ongoing operations to mid-2027
JENA,
Prof.
Select Recent Highlights and Business Update
Next steps with izicopan
In
Complete Phase 2a results are targeted for release at major scientific meetings this year. In addition, InflaRx expects to host a virtual Capital Markets Day this spring to provide clarity on izicopan’s expected clinical development path in HS, greater insight into the HS market opportunity, and updated thinking on izicopan’s clinical utility in select additional I&I indications, including AAV.
As the Company evaluates the optimal strategy to fully realize izicopan’s potential as a pipeline-in-a-product, it is actively reviewing and considering additional development in AAV. Izicopan was designed as a best-in-class therapy, offering differentiated chemistry, metabolic properties, and safety advantages over the currently marketed C5aR inhibitor. This includes minimal CYP3A4/5 inhibition measured in pre-clinical studies, which suggests a low potential for drug-drug interactions and liver toxicity. The Company believes these features could unlock significant opportunities for development across multiple meaningful I&I markets, including AAV, where safer and more active drugs are needed.
Furthermore, with the goal of generating proof-of-concept data in additional I&I indications as efficiently as possible, InflaRx intends to conduct a PK bridging study with izicopan in
Summary of izicopan Phase 2a data in HS and CSU reported to date
In HS, izicopan induced rapid, meaningful and consistent reductions in the number of abscesses and nodules (ANs) and draining tunnels (dTs), in addition to improvements in measures such as HiSCR, IHS4, NRS30, and DLQI. Improvements in reported efficacy measures were largely rapid and consistent, beginning from Week 1, and deepened over the 4-week treatment period. Furthermore, initial data reported from 25 HS patients who completed the 4-week off-drug follow-up period showed that HiSCR responses continued to deepen four weeks after the treatment period. No signals of safety concern were detected. Given this positive biologic-like emerging clinical profile, InflaRx believes izicopan’s market opportunity in HS could substantially exceed
In CSU, reported improvements in clinical measures such as UAS7 indicate a level of activity that exceeds average historically reported placebo levels and is within the range of existing approved CSU therapies. Furthermore, in the subset of patients with severe CSU at baseline (UAS7 of 28–42) and those who presented with angioedema, the improvement appeared greater. Initial data reported from patients who completed the 4-week off-drug observational follow-up period indicated that patients continued to benefit from izicopan four weeks after the last dose. No signals of safety concern were detected. Overall, InflaRx believes these data suggest that izicopan is active in CSU. Given this positive emerging clinical profile and an addressable market for izicopan that InflaRx believes could exceed
Vilobelimab for pyoderma gangrenosum (PG)
In
In addition, late-breaking abstract titled “Vilobelimab Treatment for Ulcerative Pyoderma Gangrenosum: Results from a Multicenter, Randomized, Placebo Controlled Phase 3 Trial” has been selected for an oral presentation during the
Dr.
2025 Financial Highlights
GOHIBIC revenue and cost of sales
As part of its strategy focused on capital-efficient execution announced in
Cost of sales expenses increased by €4.0 million for the year ended
Marketing and sales expenses
Marketing and sales expenses for the twelve months ended
Research and development expenses
Research and development expenses decreased by €9.6 million for the year ended
General and administrative expenses
General and administrative expenses increased by €0.5 million to €13.5 million for the year ended
Other income
Other income decreased by €2.6 million for the year ended
Net financial result
For the twelve months ended
Net loss
For the years ended
Liquidity and capital resources
As of
Net cash used in operating activities
Net cash used in operating activities increased to €35.3 million in the year ended
Net cash from investing activities
Net cash used in investing activities during the year ended
Net cash from financing activities
Net cash generated from financing activities increased to €33.3 million in the year ended
Consolidated statements of operations and comprehensive loss for the years ended
| 2025 | 2024 | 2023 | |||||||
| (in €, except for share data) | |||||||||
| Revenues | 29,331 | 165,789 | 63,089 | ||||||
| Cost of sales | (7,267,618 | ) | (3,317,039 | ) | (532,262 | ) | |||
| Gross profit | (7,238,287 | ) | (3,151,250 | ) | (469,173 | ) | |||
| Marketing and sales expenses | (4,482,011 | ) | (6,756,595 | ) | (4,001,299 | ) | |||
| Research and development expenses | (25,720,788 | ) | (35,363,897 | ) | (41,024,131 | ) | |||
| General and administrative expenses | (13,475,085 | ) | (13,024,441 | ) | (12,628,756 | ) | |||
| Other income | 2,671,380 | 5,287,616 | 13,219,704 | ||||||
| Other expenses | (14,629 | ) | (297 | ) | (4,440 | ) | |||
| Operating result | (48,259,420 | ) | (53,008,864 | ) | (44,908,096 | ) | |||
| Finance income | 1,845,428 | 3,196,813 | 3,804,827 | ||||||
| Finance expenses | (39,239 | ) | (20,655 | ) | (35,628 | ) | |||
| Foreign exchange result | (4,852,203 | ) | 3,670,235 | (1,841,872 | ) | ||||
| Other financial result | 5,683,935 | 103,285 | 313,240 | ||||||
| Income taxes | (12,282 | ) | (5,217 | ) | — | ||||
| Loss for the period | (45,633,780 | ) | (46,064,402 | ) | (42,667,529 | ) | |||
| Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | |||||||||
| Exchange differences on translation of foreign currency | (269,131 | ) | 58,344 | 125,085 | |||||
| TOTAL COMPREHENSIVE LOSS | (45,902,911 | ) | (46,006,058 | ) | (42,542,444 | ) | |||
| Share information | |||||||||
| Weighted average number of shares outstanding | 67,288,321 | 58,919,958 | 54,940,137 | ||||||
| Loss per share (basic/diluted) | (0.68 | ) | (0.78 | ) | (0.78 | ) | |||
InflaRx N.V. and subsidiaries
Unaudited condensed consolidated statements of financial position as of
2025 | 2024 | |||||
| ASSETS | (in €) | |||||
| Non-current assets | ||||||
| Property and equipment | 289,317 | 256,280 | ||||
| Right-of-use assets | 861,667 | 758,368 | ||||
| Intangible assets | 42,255 | 50,781 | ||||
| Other assets | 151,198 | 204,233 | ||||
| Financial assets | 237,373 | 3,092,290 | ||||
| Total non-current assets | 1,581,810 | 4,361,952 | ||||
| Current assets | ||||||
| Inventories | — | 6,897,666 | ||||
| Current other assets | 3,261,038 | 5,103,402 | ||||
| Other assets from government grants and research allowance | 2,487,763 | 5,081,772 | ||||
| Tax receivable | 1,428,428 | 1,735,335 | ||||
| Financial assets | 30,435,088 | 34,462,352 | ||||
| Cash and cash equivalents | 16,022,171 | 18,375,979 | ||||
| Total current assets | 53,634,487 | 71,656,505 | ||||
| TOTAL ASSETS | 55,216,297 | 76,018,457 | ||||
| EQUITY AND LIABILITIES | ||||||
| Equity | ||||||
| Issued capital | 8,675,143 | 7,122,205 | ||||
| Share premium | 354,975,760 | 334,929,685 | ||||
| Other capital reserves | 48,560,500 | 44,115,861 | ||||
| Accumulated deficit | (377,826,001 | ) | (332,192,221 | ) | ||
| Other components of equity | 7,171,379 | 7,440,510 | ||||
| Total equity | 41,556,781 | 61,416,039 | ||||
| Non-current liabilities | ||||||
| Lease liabilities | 640,973 | 399,066 | ||||
| Other liabilities | 36,877 | 36,877 | ||||
| Total non-current liabilities | 677,850 | 435,943 | ||||
| Current liabilities | ||||||
| Trade and other payables | 5,399,383 | 11,394,232 | ||||
| Lease liabilities | 256,943 | 406,020 | ||||
| Employee benefits | 1,164,259 | 2,064,678 | ||||
| Liabilities to warrant holders | 5,802,128 | — | ||||
| Other liabilities | 358,954 | 301,544 | ||||
| Total current liabilities | 12,981,666 | 14,166,475 | ||||
| Total liabilities | 13,659,516 | 14,602,417 | ||||
| TOTAL EQUITY AND LIABILITIES | 55,216,297 | 76,018,457 | ||||
Unaudited condensed consolidated statements of changes in shareholders’ equity
for the twelve months ended
| in € | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other components of equity | Total equity | |||||||||||
| Balance as of | 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 | 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 | 7,122,205 | 334,929,685 | 44,115,861 | (332,192,221 | ) | 7,440,510 | 61,416,039 | ||||||||||
| Loss for the Period | — | — | — | (45,633,780 | ) | — | (45,633,780 | ) | |||||||||
| Exchange differences on translation of foreign currency | — | — | — | — | (269,131 | ) | (269,131 | ) | |||||||||
| Total Comprehensive Loss | — | — | — | (45,633,780 | ) | (269,131 | ) | (45,902,911 | ) | ||||||||
| Issuance of ordinary shares | 1,552,938 | 21,347,913 | — | — | — | 22,900,851 | |||||||||||
| Transaction costs | — | (1,301,837 | ) | — | — | — | (1,301,837 | ) | |||||||||
| Equity-settled share-based payments | — | — | 4,444,639 | — | — | 4,444,639 | |||||||||||
| Balance as of | 8,675,143 | 354,975,760 | 48,560,500 | (377,826,001 | ) | 7,171,379 | 41,556,781 | ||||||||||
Unaudited condensed consolidated statements of cash flows for the twelve months ended
| 2025 | 2024 | 2023 | |||||||
| (in €) | |||||||||
| Operating activities | |||||||||
| Loss for the period | (45,633,780 | ) | (46,064,402 | ) | (42,667,529 | ) | |||
| Adjustments for: | |||||||||
| Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | 419,483 | 485,114 | 567,780 | ||||||
| Net finance income | (2,637,922 | ) | (6,949,679 | ) | (2,240,566 | ) | |||
| Share-based payment expense | 4,444,639 | 4,065,807 | 3,414,489 | ||||||
| Net foreign exchange differences | 1,533,408 | (37,101 | ) | 413,017 | |||||
| Changes in: | |||||||||
| Other assets from government grants and research allowances | 2,594,009 | (5,081,772 | ) | 732,971 | |||||
| Other assets and trade receivables | 2,202,304 | 1,042,513 | 7,825,181 | ||||||
| Employee benefits | (900,419 | ) | 454,912 | 297,518 | |||||
| Other liabilities | 57,410 | (2,584,228 | ) | 2,738,164 | |||||
| Liabilities from government grants received | — | — | (6,209,266 | ) | |||||
| Trade and other payables | (5,994,849 | ) | (580,129 | ) | 6,986,824 | ||||
| Inventories | 6,897,666 | 4,470,141 | (11,367,807 | ) | |||||
| Interest received | 1,738,197 | 2,243,197 | 1,732,284 | ||||||
| Interest paid | (34,474 | ) | (21,064 | ) | (36,025 | ) | |||
| Net cash used in operating activities | (35,314,328 | ) | (48,556,690 | ) | (37,812,966 | ) | |||
| Investing activities | |||||||||
| Purchase of intangible assets and property and equipment | (115,694 | ) | (46,871 | ) | (81,100 | ) | |||
| Purchase of current and non-current financial assets | (46,100,315 | ) | (35,340,107 | ) | (104,051,972 | ) | |||
| Proceeds from sale of current financial assets | 49,449,058 | 87,751,331 | 86,436,456 | ||||||
| Net cash from/ (used in) investing activities | 3,233,048 | 52,364,354 | (17,696,616 | ) | |||||
| Financing activities | |||||||||
| Proceeds from issuance of ordinary shares | 22,900,851 | 1,098,289 | 56,483,929 | ||||||
| Proceeds from pre-funded warrants | 12,915,909 | — | — | ||||||
| Transaction costs from issuance of ordinary shares and pre-funded warrants | (2,142,530 | ) | (323,729 | ) | (3,360,626 | ) | |||
| Proceeds from exercise of share options | — | — | 236,943 | ||||||
| Repayment of lease liabilities | (357,583 | ) | (388,114 | ) | (373,977 | ) | |||
| Net cash from financing activities | 33,316,646 | 386,446 | 52,986,269 | ||||||
| Net in-/decrease in cash and cash equivalents | 1,235,366 | 4,194,110 | (2,523,313 | ) | |||||
| Effect of exchange rate changes on cash and cash equivalents | (3,589,174 | ) | 1,413,926 | (974,099 | ) | ||||
| Cash and cash equivalents at beginning of period | 18,375,979 | 12,767,943 | 16,265,355 | ||||||
| Cash and cash equivalents at end of period | 16,022,171 | 18,375,979 | 12,767,943 | ||||||
About GOHIBIC (vilobelimab)
In
In the
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
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 =3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.
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 izicopan
Izicopan 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 and in human studies. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan 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 izicopan was well tolerated in treated subjects and exhibited no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of izicopan, with a =90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern. In patients with hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7).
About
InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx‘s lead program is izicopan, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The Company is developing izicopan for the treatment of several inflammatory diseases, including hidradenitis suppurativa. InflaRx also has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies.
InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and
Contacts:
Vice President, Head of Investor Relations Email: IR@inflarx.de | Email: inflarx@mc-services.eu |
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the success of our future clinical trials for vilobelimab's treatment of other debilitating or life-threatening inflammatory indications, including acute respiratory distress syndrome, or ARDS; the potential strategic transactions or collaborations, including a potential partnership of izicopan, or vilobelimab for PG; the success of our future clinical trials for izicopan, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of pre-clinical studies and clinical trials of vilobelimab, izicopan and any other of our product candidates and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our biologics license application submission for GOHIBIC (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication; whether the FDA, or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediated immunological and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of such protection; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval or commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the
