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, Germany, March 19, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (NASDAQ:IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced its financial results for the three and twelve months ended December 31, 2025, and provided a business update.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: "With the strong Phase 2a results reported in hidradenitis suppurativa and chronic spontaneous urticaria, and its best-in-class potential, we made the strategic decision to focus our resources on izicopan. We are in active discussions with the FDA for the design of our Phase 2b trial in HS and look forward to establishing a clear path forward soon. By tightly focusing the Company on izicopan in select inflammation and immunology indications, we believe we are well positioned to advance to the next stage of development and effectively execute our plans."
Select Recent Highlights and Business Update
Next steps with izicopanIn November 2025, InflaRx announced positive topline data from a Phase 2a basket study exploring izicopan in HS and chronic spontaneous urticaria (CSU). InflaRx believes results from this study provide strong rationale for further development, with a priority placed on HS. In HS, InflaRx has made substantial progress towards Phase 2b readiness and expects to close out communications with the FDA in the upcoming months. In CSU, where InflaRx continues to weigh options, the Company remains in ongoing dialog with key opinion leaders who remain supportive of izicopan's potential in CSU to address unmet need.
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 China this year to expedite subsequent proof-of-concept studies in China and elsewhere.
Summary of izicopan Phase 2a data in HS and CSU reported to dateIn 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 $1 billion.
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 $1 billion, the Company is considering further development for izicopan in CSU.
Vilobelimab for pyoderma gangrenosum (PG)In December 2025, InflaRx announced that post-hoc analyses performed on the Phase 3 trial for vilobelimab in PG previously terminated for futility suggest a positive trend in favor of vilobelimab. The analyses found signals indicating a consistent treatment effect on clinical measures such as disease remission, proportion of patients with >50% reduction of target ulcer volume, DLQI, and ulcer volume mean change from baseline. While InflaRx is currently prioritizing its HS-related interactions with the dermatology division of the FDA, the Company continues to anticipate meeting with the agency to determine a potential development path forward for vilobelimab in PG. InflaRx expects that any future development activities in PG would likely be conducted only in collaboration with a partner.
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 Late-Breaking Research abstract session at the 2026 American Academy of Dermatology (AAD) Annual Meeting on March 28, 2026, 2:24-2:36 PM MT.
Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: "Our goal is to implement a clear, focused strategy that directs our resources toward izicopan, our highest value asset and pipeline-in-a-product. With this focus and related significant cost reductions, we have a projected cash runway to mid-2027 and believe we are well positioned to execute on our key milestones and the next phase of our clinical development plan."
2025 Financial Highlights
GOHIBIC revenue and cost of salesAs part of its strategy focused on capital-efficient execution announced in January 2026, InflaRx carried out significant reductions in GOHIBIC (vilobelimab) commercial spending and related functions, including personnel-related costs, as well as the termination or modification of certain third-party contracts. InflaRx will keep GOHIBIC (vilobelimab) available for ordering inside the United States under its Emergency Use Authorization and maintain the ability to satisfy demand in the United States on a reactive basis.
Cost of sales expenses increased by €4.0 million for the year ended December 31, 2025 compared to the corresponding costs for the year ended December 31, 2024 primarily due to higher inventory write-downs of €4.0 million. As a result of the scaling back and discontinuation of GOHIBIC sales activities in the United States, the related inventory has been fully written down.
Marketing and sales expensesMarketing and sales expenses for the twelve months ended December 31, 2025 decreased by €2.3 million compared to the twelve months ended December 31, 2024. This decrease was primarily due to lower costs in external services for distribution and marketing expenses.
Research and development expensesResearch and development expenses decreased by €9.6 million for the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due to lower third-party costs from manufacturing development activities and from clinical trials, which decreased by €7.2 million, and €2.2 million lower other expenses compared to the previous year.
General and administrative expensesGeneral and administrative expenses increased by €0.5 million to €13.5 million for the year ended December 31, 2025, from €13.0 million for the year ended December 31, 2024. This increase is comprised of higher legal and consulting fees by €0.6 million and higher personnel expenses by €0.3 million, offset by €0.5 million lower other expenses, associated with insurance expenses.
Other incomeOther income decreased by €2.6 million for the year ended December 31, 2025, compared to the year ended December 31, 2024, due primarily to lower income from government grants and research allowances. In 2024, upon qualifying for an allowance under the German Research Allowance Act, InflaRx recognized €5.1 million in income relating to expenses eligible for reimbursement, which were incurred in the years 2020 to 2024. In 2025, we recognized €2.6 million for the year 2025. We remain eligible for reimbursement of eligible expenses to be incurred from 2026 to 2027.
Net financial resultFor the twelve months ended December 31, 2025, net financial result decreased by €4.3 million from a gain of €6.9 million in the twelve months ended December 31, 2024. This decrease was mainly attributable to the decrease of the foreign exchange result by €8.5 million due to the weakening of the U.S. dollar. Financial result decreased by €1.4 million due to lower interest income on marketable securities. This effect was partially offset by a gain of €5.7 million from the fair value remeasurement of pre-funded warrants issued in February 2025.
Net lossFor the years ended December 31, 2025, and 2024, the Company incurred net losses of €45.6 million or €0.68 per ordinary share and €46.1 million or €0.78 per ordinary share, respectively.
Liquidity and capital resourcesAs of December 31, 2025, total funds available amounted to approximately €46.2 million, comprised of €16.0 million in cash and cash equivalents and €30.2 million in marketable securities.
Net cash used in operating activitiesNet cash used in operating activities increased to €35.3 million in the year ended December 31, 2025, from €48.6 million in the year ended December 31, 2024.
Net cash from investing activitiesNet cash used in investing activities during the year ended December 31, 2025 amounted to €3.2 million due to lower proceeds from sales of marketable securities. During the previous year ending on December 31, 2024, the Company had a net cash outflow of €52.4 million due to more cash outflows from the purchase of marketable securities than inflows from the proceeds from sales of marketable securities.
Net cash from financing activitiesNet cash generated from financing activities increased to €33.3 million in the year ended December 31, 2025, from €0.4 million in the year ended December 31, 2024, primarily due to higher proceeds from the issuance of shares and pre-funded warrants.
InflaRx N.V. and subsidiaries
Consolidated statements of operations and comprehensive loss for the years ended December 31, 2025, 2024 and 2023
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 December 31, 2025 and December 31, 2024
December 31,2025
December 31,2024
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
