Full Press Release Details
InflaRx Reports Full Year 2024 Results and
Highlights Key Achievements and Expected Milestones
Jena, Germany, March 20, 2025 - 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 $1 billion or more for INF904. The Company also believes INF904 could address meaningful opportunities in additional immuno-dermatology and
immuno-inflammatory indications, including in nephrology, neurology and hematology. While InflaRx intends to focus its resources on its immediate goals addressing CSU and HS, the Company continues to assess and monitor the value of pursuing
additional areas and applications via potential future collaborations with partners.
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 28.7 million ($30.0 million), before deducting the
underwriting discount and offering expenses.
2024 Financial highlights
In 2024, we realized revenues from product sales of GOHIBIC (vilobelimab) in the amount of 0.2 million, which represents an increase of 0.1 million compared to the prior year. Revenues reported are sales to end
customers (hospitals). Sales to distributors do not constitute revenue for the Company. All revenues are attributed to sales made in the United States.
Cost of sales increased by 2.8 million in 2024 compared to the corresponding costs for 2023, primarily due to higher inventory write-downs of 2.8 million as a result of quantities on hand exceeding quantities
expected to be sold prior to expiry.
Marketing and sales expenses
Marketing and sales expenses increased by 2.8 million in 2024 compared to 2023, as 2024 represented the first full year of commercial efforts for GOHIBIC (vilobelimab) in the United States. In 2023, marketing and
sales expenses were only incurred during the second half of the year.
Research and development expenses
Research and development expenses decreased by 5.7 million to 35.4 million in 2024 compared to the year 2023. This decrease was primarily attributable to 8.7 million lower third-party costs from manufacturing
development activities and from clinical trials, offset by 1.6 million higher personnel expenses and 1.4 million higher other expenses compared to the previous year. Other expenses include a one-off milestone contractual payment of $1.0 million
( 1.0 million) relating to market authorization for GOHIBIC (vilobelimab) in the EU.
General and administrative expenses
General and administrative expenses increased by 0.4 million to 13.0 million for the year ended December 31, 2024, from 12.6 million for the year ended December 31, 2023. This increase is comprised of higher
personnel expenses of 0.9 million and partially offset by a decrease in legal and consulting expenses of 0.4 million and a decrease in insurance expenses of 0.4 million.
Other income decreased by 7.9 million in 2024 compared to the year 2023 due primarily to lower income from government grants. In June 2023, our grant from the German Ministry of Education and Research and the German
Ministry of Health to support the development of vilobelimab for the treatment of severe COVID-19 patients ended. In 2024, upon qualifying for an allowance under the German Research Allowance Act, we recognized 5.1 million in income relating to
expenses, eligible for reimbursement, which were incurred in the years 2020 to 2024. We remain eligible for additional research allowances for eligible expenses to be incurred from 2025 to 2027.
Net financial result
Net financial result increased by 4.7 million to a gain of 6.9 million in 2024 compared to 2.2 million in 2023. This overall net increase is mainly attributable to an increase of 5.5 million in foreign exchange
results, partially offset by 0.6 million lower interest income from marketable securities compared to 2023.
We incurred a net loss of 46.1 million, or 0.78 per ordinary share, in 2024, compared to 42.7 million, or 0.78 per ordinary share, in 2023.
Liquidity and capital resources
As of December 31, 2024, our total funds available amounted to approximately 55.2 million, comprised of 18.4 million of cash and cash equivalents and 36.8 million of marketable securities.
Net cash used in operating activities
Net cash used in operating activities increased to 48.6 million in 2024, from 37.8 million in 2023, mainly due to lower income recognized from German federal government grants and research allowances.
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 re- serves | Accumulated deficit | Other compo- nents 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 pay-ments | - | - | 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 pay-ments | - | - | 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 pay-ments | - | - | 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 23.9% compared to placebo in the global data set. The data were published in The Lancet Respiratory Medicine.
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