Full Press Release Details
InflaRx Reports Full Year 2025 Results
Key Achievements and Expected Milestones
Jena, Germany, March 19, 2026 - 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 izicopan
In 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
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 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 $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
Vilobelimab for pyoderma gangrenosum (PG)
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 sales
As 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 expenses
Marketing 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 expenses
Research 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 expenses
General 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 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 result
For 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.
For the years ended December 31, 2025, and 2024,