InflaRx Reports Full Year 2024 Results and Highlights Key Achievements and Expected Milestones

   -- Received European Commission approval for GOHIBIC$(R)$ (vilobelimab) for 
      the treatment of SARS-CoV-2-induced acute respiratory distress syndrome 
      $(ARDS)$ 
 
   -- Achieved 30-patient recruitment milestone in Phase 3 vilobelimab trial in 
      pyoderma gangrenosum $(PG)$ to enable an expected interim analysis for 
      trial size adaptation or futility by the end of May 2025 
 
   -- Dosed first patient in Phase 2a trial for oral C5aR inhibitor, INF904, 
      with topline data in chronic spontaneous urticaria (CSU) and hidradenitis 
      suppurativa (HS) expected in summer 2025 
 
   -- Multiple data presentations at AAD 2025 highlighting the potential of 
      vilobelimab in reducing systemic inflammation 
 
   -- Cash, cash equivalents and marketable securities of EUR55.2 million as of 
      December 31, 2024 
 
   -- Additional EUR28.7 million ($30.0 million) in gross proceeds subsequently 
      raised by an underwritten public offering of ordinary shares and 
      pre-funded warrants on February 18, 2025 
 
   -- InflaRx's cash runway significantly extended, with sufficient cash, cash 
      equivalents and marketable securities to fund currently planned 
      operations into 2027 

JENA, Germany, March 20, 2025 (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 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 $(IMV.UK)$ 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 EUR28.7 million ($30.0 million), before deducting the underwriting discount and offering expenses.

2024 Financial highlights

Revenue

In 2024, we realized revenues from product sales of GOHIBIC (vilobelimab) in the amount of EUR0.2 million, which represents an increase of EUR0.1 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

Cost of sales increased by EUR2.8 million in 2024 compared to the corresponding costs for 2023, primarily due to higher inventory write-downs of EUR2.8 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 EUR2.8 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 EUR5.7 million to EUR35.4 million in 2024 compared to the year 2023. This decrease was primarily attributable to EUR8.7 million lower third-party costs from manufacturing development activities and from clinical trials, offset by EUR1.6 million higher personnel expenses and EUR1.4 million higher other expenses compared to the previous year. Other expenses include a one-off milestone contractual payment of $1.0 million (EUR1.0 million) relating to market authorization for GOHIBIC (vilobelimab) in the EU.

General and administrative expenses

General and administrative expenses increased by EUR0.4 million to EUR13.0 million for the year ended December 31, 2024, from EUR12.6 million for the year ended December 31, 2023. This increase is comprised of higher personnel expenses of EUR0.9 million and partially offset by a decrease in legal and consulting expenses of EUR0.4 million and a decrease in insurance expenses of EUR0.4 million.

Other income

Other income decreased by EUR7.9 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 EUR5.1 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 EUR4.7 million to a gain of EUR6.9 million in 2024 compared to EUR2.2 million in 2023. This overall net increase is mainly attributable to an increase of EUR5.5 million in foreign exchange results, partially offset by EUR0.6 million lower interest income from marketable securities compared to 2023.

Net loss

We incurred a net loss of EUR46.1 million, or EUR0.78 per ordinary share, in 2024, compared to EUR42.7 million, or EUR0.78 per ordinary share, in 2023.

Liquidity and capital resources

As of December 31, 2024, our total funds available amounted to approximately EUR55.2 million, comprised of EUR18.4 million of cash and cash equivalents and EUR36.8 million of marketable securities.

Net cash used in operating activities

Net cash used in operating activities increased to EUR48.6 million in 2024, from EUR37.8 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 $(SEC.UK)$.

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 EUR, 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,    December 31, 
                                               2024            2023 
                                          -------------  --------------- 
ASSETS                                               (in EUR) 
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

 
                                            Other                                    Other 
                  Issued       Share        capital    AcSHYcuSHYmuSHYlated   comSHYSHYpoSHYnents       Total 
in EUR            capital    preSHYmium    reserves           deficit              of equity            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 
 paySHYments            --           --    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 
 paySHYments            --           --    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 
 paySHYments            --           --    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 EUR) 
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 of using GOHIBIC (vilobelimab) to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC (vilobelimab) website http://www.gohibic.com.

Important Safety Information about GOHIBIC (vilobelimab)

There are 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 and 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.

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.

About 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.

Vilobelimab is being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (PG). Vilobelimab has been granted orphan drug designation for the treatment of PG by both the FDA and the 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 $(BID.AU)$ for 14 days. PK / pharmacodynamic data support the best-in-class potential of INF904 with a >=90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period.

About InflaRx N.V.

InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. $(USA)$ are wholly owned subsidiaries of InflaRx N.V. (together, 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 C5a-induced signaling via 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.de.

Contacts:

 
InflaRx N.V.                            MC Services AG 
--------------------------------------  -------------------------------------- 
Jan Medina, CFA Vice President, Head    Katja Arnold, Laurie Doyle, Dr. Regina 
of Investor Relations Email:            Lutz Email: inflarx@mc-services.eu 
IR@inflarx.de                           Europe: +49 89-210 2280 U.S.: 
                                        +1-339-832-0752 
--------------------------------------  -------------------------------------- 
 

(* Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions provided on the webpage: The InflaRx Commitment Program.)

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 receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals and related treatment recommendations by medical/healthcare institutes and other third-party organizations, our ability to successfully commercialize and the receptiveness of GOHIBIC (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indications or for vilobelimab and any other product candidates, under an EUA and in the future if approved for commercial use in the U.S. or elsewhere; our ability to successfully implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab's treatment of COVID-19 and other debilitating or life-threatening inflammatory indications, including PG, and any other product candidates, including INF904, 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 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 expectations regarding the scope of any approved indication for vilobelimab; our ability to leverage our proprietary anti-C5a and C5aR technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab 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 and 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 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.

(END) Dow Jones Newswires

March 20, 2025 07:30 ET (11:30 GMT)