InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering
anti-inflammatory therapeutics by targeting the complement system,
today announced its financial and operating results for the year
ended December 31, 2023, and provided a comprehensive strategic
update on its future development and operational plans.
Prof. Niels C. Riedemann, Chief
Executive Officer and Founder of InflaRx, commented:
“InflaRx has recently made tremendous progress in its pipeline,
with vilobelimab now in Phase III for PG and INF904 emerging
as a potentially best-in-class oral C5aR inhibitor with broad
commercial potential. It’s with great excitement that we unveil our
new pipeline focus directed at sizable markets and unmet needs in
immuno-dermatology where our unique approach to C5a and C5aR
inhibition may provide significant benefits. We believe that
InflaRx can drive incremental pipeline value in this field given
our expertise and network. Furthermore, with the potential of
INF904 to be a ‘pipeline-in-a-product', we are considering
partnering options to unlock additional value in other areas of
interest."
Prof. Dr. Marcus Maurer, Chairman of
Dermatology and Allergology, Institute of Allergology, Charité
University, Berlin, Germany, commented: “I am very excited
about the development of INF904 and its initial focus on the
immuno-dermatology field, including CSU where our group has worked
out and communicated to InflaRx a potential role of C5aR in the
disease pathology. As a potent oral inhibitor of C5aR, I believe
there is a strong rationale to pursue development of INF904 in CSU,
a condition with high unmet patient need and where new mechanisms
of action are needed. I look forward to future collaboration with
InflaRx on this promising agent."
Christopher Sayed, MD, Prof. of
Dermatology, University of North Carolina, Medical School; and
Secretary of the HS Foundation, commented: “There has been
accumulating evidence from clinical studies, some of which I have
been involved in, that C5a and C5aR inhibition may provide
substantial benefit to HS patients. Especially the observed effect
on reduction of draining tunnels, one of the most life-impacting
and difficult to treat lesions has been remarkable as this remains
a high unmet medical need. I am excited to see INF904 being
developed as an oral C5aR inhibitor in HS, which could represent a
promising new treatment option for these patients who need more and
differentiated therapies.”
Pipeline update event today; R&D day
to follow later this year
InflaRx will host a virtual pipeline update call
today, beginning at 8:00 AM ET / 1:00 PM CET to discuss its focus
on immuno-dermatology. The company will provide details on the
development rationales for its chosen indications for its oral C5aR
inhibitor INF904 and provide an update on the development of
vilobelimab in PG.
To participate in the conference call,
participants may pre-register here and will receive a dedicated
link and dial-in details to easily and quickly access the call. An
accompanying updated corporate deck can be found here.
InflaRx is also planning a virtual research and
development event to follow later this year to provide more details
on its development plans and to offer insights from key opinion
leaders into the development and commercial rationales of InflaRx’s
pipeline.
Immuno-dermatology pipeline focus:
INF904 for CSU and HS
InflaRx has chosen two initial
immuno-dermatology indications that it intends to pursue with
INF904 via the initiation of a Phase IIa “basket study”. These
indications initially include CSU and HS, two chronic inflammatory
skin conditions in which C5a has been suggested to play a
significant role and where a high unmet need exists. In addition,
with INF904 being an oral drug with a mechanism of action currently
not addressed by other drugs in development for these indications,
the company sees a unique opportunity to improve standard of care
for patients with these conditions. InflaRx estimates significant
market potential for INF904 in these two indications, both
estimated as multi-billion-dollar markets.
InflaRx is currently conducting additional
pre-clinical studies, including chronic toxicology studies, to
enable longer-term dosing of INF904. Consistent with previous
communications, InflaRx anticipates initiating a Phase IIa
study with INF904 before the end of 2024. This open-label
Phase IIa study is expected to explore at least three
different doses of INF904 for a duration of 4 weeks and to assess
pharmacokinetic (PK) and pharmacodynamic (PD) parameters in
patients, as well as provide safety data and certain early efficacy
readouts. Data from this Phase IIa study is expected to be released
in 2025. InflaRx expects to initiate a larger and longer-term
Phase IIb study in 2025 as well.
INF904 for CSU
CSU is a debilitating and unpredictable skin
disease characterized by intensely itchy hives / wheals and
angioedema. The burden of this chronic disease is high and impacts
sleep, mental health, quality of life and productivity due to
absences from school and work. CSU is estimated to affect around 40
million people worldwide.
CSU patients have been reported to show elevated
C5a levels, a major activator of mast cells and basophils, which
are thought to be significant contributors to CSU pathogenesis. In
addition, studies suggest that complement activation (including
C5a) in CSU can lead to histamine release.
Current treatments are limited, and a
significant unmet need exists in a sizable proportion of patients.
As an orally available agent with a favorable PK / PD profile that
could drive a broad dose range for systemic exposure, INF904 could
find a differentiated position in the CSU market.
INF904 for HS
HS is a chronic, recurrent, debilitating
neutrophil-driven inflammatory disease that can persist for years
and tremendously impacts quality of life; it is characterized by
abscesses, nodules and draining tunnels which can flare and cause
scarring.
INF904 inhibits the known C5a-induced effects on
neutrophil activation and tissue accumulation of immune cells,
including generation of tissue damaging mechanisms (enzyme release
and oxidative radical formation) as well as induction of NETosis –
mechanisms thought to be involved in HS progression and draining
tunnel formation. Clinical evidence with existing C5a/C5aR products
also supports that blocking this pathway reduces lesion counts.
Patients’ responses to treatment with approved
anti-TNF-alpha or anti-IL17 drugs are known to wane over time in a
significant number of cases, and treatments with new mechanisms are
needed for these patients. As an orally available agent with a
favorable PK / PD profile that could drive a broad dose range for
systemic exposure, INF904 could find a differentiated and
commercially advantageous place in HS treatment.
INF904 as a
“pipeline-in-a-product"
Given the potential of INF904 to have a broad
commercial footprint, InflaRx believes it could address meaningful
markets in immuno-dermatology and in immuno-inflammation, including
in neurology, nephrology and hematology. While InflaRx intends to
focus its resources on its immediate goals with CSU and HS, it also
assesses pursuit of these additional areas via potential future
collaborations with partners.
Immuno-dermatology pipeline focus:
Vilobelimab for PG
InflaRx’s strategy and planning for vilobelimab
in PG remain unchanged and its development is currently on track.
InflaRx is conducting a multi-national, randomized, double-blind,
placebo-controlled pivotal Phase III study with vilobelimab for the
treatment of ulcerative PG, a rare, chronic inflammatory form of
neutrophilic dermatosis characterized by accumulation of
neutrophils in the affected skin areas. The trial study has two
arms: (1) vilobelimab plus a low dose of corticosteroids and (2)
placebo plus the same low dose of corticosteroids. The primary
endpoint of the study is complete closure of the target ulcer at
any time up to 26 weeks after initiation of treatment.
The study has an adaptive design with an interim
analysis blinded for the sponsor and investigators planned upon
enrollment of approximately 30 patients (15 per arm). Depending on
the results of the interim analysis, the trial sample size will be
adapted, or the trial will be terminated due to futility. The
enrollment period is projected to be at least two years, depending
on the total trial size after sample size adaptation.
Vilobelimab has been granted orphan drug
designation for the treatment of PG by both the U.S. Food and Drug
Administration (FDA) in the United States and the European
Medicines Agency in Europe, as well as fast track designation by
the FDA.
Select 2023 and recent operational
highlights
INF904 - Positive topline results from
Phase I trial support best-in-class potential
In January 2024, InflaRx reported results from
the multiple ascending dose (MAD) part of a randomized,
double-blind, placebo-controlled Phase I trial in healthy
volunteers to assess the safety, tolerability and PK / PD
properties of its orally administered, low molecular weight C5aR
inhibitor, INF904.
The safety analysis of INF904 in the Phase I
study demonstrated that it was well tolerated in participants over
the entire dose range and resulted in no safety signals of concern.
There were no serious or severe adverse events observed at any
dosing level. Both the single ascending dose (SAD) and the MAD part
of the study showed very favorable PK and PD profiles, including
achieving the desired blocking activity (>90%) of C5a-induced
neutrophil activation in an ex vivo challenge assay using
physiological and disease-relevant levels of C5a.
New executives further strengthen the
InflaRx team
In July 2023, Dr. Camilla Chong was appointed as
InflaRx’s Chief Medical Officer. She brings strong global
pharmaceutical experience, having successfully led clinical
development, medical affairs, clinical operations, regulatory and
pharmacovigilance teams and managed global clinical development
programs. Dr. Chong is leading all clinical development activities
at InflaRx.
In February 2024, Jan Medina, CFA, joined
InflaRx as Vice President and Head of Investor Relations. Mr.
Medina brings over 25 years of experience across the life sciences
sector and capital markets, including in investor relations,
communications and equity research.
Financing activities
In April 2023, InflaRx issued 3,235,723 ordinary
shares under its at-the-market program, resulting in €14.4 million
in net proceeds. Also in April 2023, the company completed an
underwritten public offering of an aggregate of 10,823,529 ordinary
shares, of which 1,411,764 were sold pursuant to the full exercise
of an overallotment option granted to the underwriters. The
ordinary shares were sold at a price of $4.25 per share with a
nominal value of €0.12 per share. Aggregate proceeds from these
equity offerings amounted to €53.5 million after deducting
underwriting discounts.
Vilobelimab for the treatment of
critically Ill COVID-19 Patients
In April 2023, the FDA issued an Emergency Use
Authorization (EUA) for GOHIBIC (vilobelimab) for the treatment of
COVID-19 in hospitalized adults when initiated within 48 hours of
receiving invasive mechanical ventilation (IMV) or extracorporeal
membrane oxygenation (ECMO). In January 2024, InflaRx announced the
launch of The InflaRx Commitment Program, pursuant to which the
cost of GOHIBIC will be refunded for up to six (6) administered
inpatient doses (the full treatment course) to institutions that
meet the eligibility requirements*, for patients who were
administered GOHIBIC (vilobelimab) in line with its EUA and who
died due to COVID-19 in the intensive care unit.
InflaRx continues to explore funding options for
vilobelimab as a treatment for acute respiratory distress syndrome
(ARDS), including government grants as well as collaborations with
third parties.
The Marketing Authorization Application (MAA)
for the treatment of adult patients with SARS-CoV-2 induced septic
ARDS receiving IMV or ECMO is under regulatory review by the
European Committee for Medicinal Products for Human Use under the
centralized procedure, which applies to all 27 member states of the
European Union.
InflaRx received a total of €33.3 million to
support its COVID-19 clinical development as part of a grant
awarded by the German federal government for the period of October
2021 to June 2023.
Dr. Thomas Taapken, Chief Financial
Officer of InflaRx, said: “We closed 2023 in a strong
financial position and are well situated to advance our clinical
programs toward their next milestones. With our current resources,
we expect to be able to fund operations at least into 2026."
2023 Financial Highlights
Revenue
In 2023, for the first time since its inception,
InflaRx realized revenues from its product sales. Revenues reported
are sales to end customers (hospitals). Sales to distributors do
not constitute completion of a performance obligation towards a
customer and, thus, do not result in the recognition of revenue for
InflaRx under IFRS 15. The company is continuing its
cost-disciplined launch efforts to educate health care providers
and implement measures to make the drug available for eligible
patients.
Cost of sales
Cost of sales recognized during the twelve
months ended December 31, 2023, are related to GOHIBIC
(vilobelimab) revenues in the United States and to write-downs of
inventory.
Costs of sales for products sold in these
periods do not include costs of materials, as the associated costs
of these materials were incurred in prior periods, before the FDA
granted an EUA for GOHIBIC (vilobelimab) in April 2023. These
materials were recorded as ‘research and development expenses’ in
the periods they were incurred.
The cost of sales during the twelve months ended
December 31, 2023 mainly consisted of write-downs of inventories
that will expire prior to their expected sale.
Sales and marketing
expenses
During the twelve months ended December 31,
2023, InflaRx incurred €4.0 million of sales and marketing expenses
in the U.S. These expenses were mainly composed of €1.0 million in
personnel costs and €1.9 million in external services for
distribution of GOHIBIC (vilobelimab). The Group started with its
commercialization activities when the EUA was granted in April
2023. Prior to that, no sales and marketing expenses had been
incurred.
Research and development
expenses
InflaRx’s research and development expenses
increased by €3.5 million for the year ended December 31, 2023,
compared to the corresponding costs for the year ended December 31,
2022, primarily due to higher third-party material and
manufacturing (CDMO) costs and from clinical trials, which
increased by €1.9 million.
General and administrative
expenses
InflaRx’s general and administrative expenses
decreased by €2.2 million to €12.6 million for the year ended
December 31, 2023, from €14.9 million for the year ended
December 31, 2022. This decrease is partially attributable to a
€1.7 million decrease in personnel expenses, driven by a decrease
in expenses from share-based compensation. The decrease of other
expenses by €0.6 million is primarily attributable to lower D&O
insurance cost.
Other income
In 2023, InflaRx recognized other income of
€13.2 million, which is primarily attributable to income recognized
from grant payments received from the German federal government for
the development of vilobelimab in severe COVID-19 patients,
including expenses related to clinical development and
manufacturing process development. Other income decreased in 2023,
compared to the prior year, due to the incurrence of less expenses
eligible for reimbursement under the grant and the end of the grant
period on June 30, 2023.
Net financial result
InflaRx’s net financial result decreased by €0.5
million to €2.2 million for the year ended December 31, 2023,
compared to €2.7 million for the year ended December 31, 2022.
This overall net decrease is mainly attributable to a decrease of
€4.3 million in foreign exchange result, which was only partly
compensated by €3.2 million in higher interest income from
marketable securities compared to the year ended December 31,
2022.
Net loss
InflaRx incurred a net loss of €42.7 million, or
€0.78 per common share, in 2023 compared to €29.5 million, or €0.67
per common share, in 2022.
Liquidity and capital
resources
As of December 31, 2023, InflaRx’s total funds
available amounted to approximately €98.4 million, comprised
of €12.8 million of cash and cash equivalents and
€85.7 million of marketable securities.
Net cash used in operating
activities
InflaRx’s net cash used in operating activities
increased to €37.8 million in the year ended December 31, 2023,
from €33.8 million in the year ended December 31, 2022, mainly due
to lower income recognized from the German federal government
grant, significant production of inventory, as well as higher
expenditures from marketing and sales activities for GOHIBIC
(vilobelimab), which were recorded for the first time due to the
start of the commercialization of this product in 2023.
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
subsidiariesConsolidated statements of operations
and comprehensive loss for the years ended
December 31, 2023, 2022 and 2021
|
2023 |
|
|
2022 |
|
|
2021 |
|
|
(in €, except for share data) |
|
|
|
|
Revenues |
63,089 |
|
|
— |
|
|
— |
|
Cost of sales |
(532,262 |
) |
|
— |
|
|
— |
|
Gross profit |
(469,173 |
) |
|
— |
|
|
— |
|
Sales and marketing expenses |
(4,001,299 |
) |
|
— |
|
|
— |
|
Research and development expenses |
(41,024,131 |
) |
|
(37,526,090 |
) |
|
(35,697,935 |
) |
General and administrative expenses |
(12,628,756 |
) |
|
(14,869,564 |
) |
|
(11,984,722 |
) |
Other income |
13,219,704 |
|
|
20,159,169 |
|
|
54,221 |
|
Other expenses |
(4,440 |
) |
|
(1,381 |
) |
|
(6,381 |
) |
Operating result |
(44,908,096 |
) |
|
(32,237,866 |
) |
|
(47,634,817 |
) |
Finance income |
3,804,827 |
|
|
608,679 |
|
|
109,391 |
|
Finance expenses |
(35,628 |
) |
|
(45,250 |
) |
|
(24,769 |
) |
Foreign exchange result |
(1,841,872 |
) |
|
2,442,297 |
|
|
1,964,135 |
|
Other financial result |
313,240 |
|
|
(252,471 |
) |
|
(44,000 |
) |
Income taxes |
— |
|
|
— |
|
|
— |
|
Loss for the period |
(42,667,529 |
) |
|
(29,484,611 |
) |
|
(45,630,059 |
) |
Other comprehensive income (loss) that may be reclassified to
profit or loss in subsequent periods: |
|
|
|
Exchange differences on translation of foreign currency |
125,085 |
|
|
4,206,810 |
|
|
6,777,061 |
|
TOTAL COMPREHENSIVE LOSS |
(42,542,444 |
) |
|
(25,277,801 |
) |
|
(38,852,998 |
) |
|
|
|
|
Share information (based on loss for the
period) |
|
|
|
Weighted average number of shares outstanding |
54,940,137 |
|
|
44,207,873 |
|
|
41,629,974 |
|
Loss per share (basic/diluted) |
(0.78 |
) |
|
(0.67 |
) |
|
(1.10 |
) |
LOSS FOR THE PERIOD |
(42,667,529 |
) |
|
(29,484,611 |
) |
|
(45,630,059 |
) |
InflaRx N.V. and
subsidiariesConsolidated statements of financial
position as of December 31, 2023 and 2022
|
December 31, 2023 |
|
|
December 31, 2022 |
ASSETS |
(in €) |
Non-current assets |
|
|
Property and equipment |
289,577 |
|
|
328,920 |
|
Right-of-use assets |
1,071,666 |
|
|
1,311,809 |
|
Intangible assets |
68,818 |
|
|
138,905 |
|
Other assets |
257,267 |
|
|
308,066 |
|
Financial assets |
9,052,741 |
|
|
2,900,902 |
|
Total non-current assets |
10,740,069 |
|
|
4,988,602 |
|
Current assets |
|
|
Inventories |
11,367,807 |
|
|
— |
|
Current other assets |
4,036,650 |
|
|
14,170,510 |
|
Tax receivable |
3,791,564 |
|
|
1,432,087 |
|
Financial assets from government grants |
— |
|
|
732,971 |
|
Other financial assets |
77,504,518 |
|
|
64,810,135 |
|
Cash and cash equivalents |
12,767,943 |
|
|
16,265,355 |
|
Total current assets |
109,468,483 |
|
|
97,411,058 |
|
TOTAL ASSETS |
120,208,552 |
|
|
102,399,660 |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
Equity |
|
|
Issued capital |
7,065,993 |
|
|
5,364,452 |
|
Share premium |
334,211,338 |
|
|
282,552,633 |
|
Other capital reserves |
40,050,053 |
|
|
36,635,564 |
|
Accumulated deficit |
(286,127,819 |
) |
|
(243,460,290 |
) |
Other components of equity |
7,382,166 |
|
|
7,257,081 |
|
Total equity |
102,581,730 |
|
|
88,349,440 |
|
Non-current liabilities |
|
|
Lease liabilities |
745,716 |
|
|
987,307 |
|
Other liabilities |
36,877 |
|
|
36,877 |
|
Total non-current liabilities |
782,593 |
|
|
1,024,184 |
|
Current liabilities |
|
|
Trade and other payables |
11,974,362 |
|
|
4,987,538 |
|
Liabilities from government grants |
— |
|
|
6,209,266 |
|
Lease liabilities |
374,329 |
|
|
369,376 |
|
Employee benefits |
1,609,766 |
|
|
1,312,248 |
|
Other liabilities |
2,885,772 |
|
|
147,608 |
|
Total current liabilities |
16,844,229 |
|
|
13,026,036 |
|
Total liabilities |
17,626,822 |
|
|
14,050,220 |
|
TOTAL EQUITY AND LIABILITIES |
120,208,552 |
|
|
102,399,660 |
|
|
|
|
InflaRx N.V. and
subsidiariesConsolidated statements of changes in
shareholders’ equity for the years ended
December 31, 2023, 2022 and 2021
in € |
Issued capital |
|
|
Share premium |
|
|
Other capital reserves |
|
|
Accumulated deficit |
|
|
Other components of equity |
|
|
Total equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 01, 2021 |
3,387,410 |
|
|
220,289,876 |
|
|
26,259,004 |
|
|
(168,345,620 |
) |
|
(3,726,791 |
) |
|
77,863,880 |
|
Loss for the Period |
— |
|
|
— |
|
|
— |
|
|
(45,630,059 |
) |
|
— |
|
|
(45,630,059 |
) |
Exchange differences on translation of foreign currency |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
6,777,061 |
|
|
6,777,061 |
|
Total Comprehensive Loss |
— |
|
|
— |
|
|
— |
|
|
(45,630,059 |
) |
|
6,777,061 |
|
|
(38,852,998 |
) |
Issuance of common shares |
1,873,203 |
|
|
63,269,346 |
|
|
— |
|
|
— |
|
|
— |
|
|
65,142,549 |
|
Transaction costs |
— |
|
|
(4,219,222 |
) |
|
— |
|
|
— |
|
|
— |
|
|
(4,219,222 |
) |
Equity-settled share-based payments |
— |
|
|
— |
|
|
4,332,205 |
|
|
— |
|
|
— |
|
|
4,332,205 |
|
Share options exercised |
43,839 |
|
|
970,744 |
|
|
— |
|
|
— |
|
|
— |
|
|
1,014,583 |
|
Balance as of December 31, 2021 |
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 common shares |
60,000 |
|
|
2,289,624 |
|
|
— |
|
|
— |
|
|
— |
|
|
2,349,624 |
|
Transaction costs |
— |
|
|
(47,735 |
) |
|
— |
|
|
— |
|
|
— |
|
|
(47,735 |
) |
Equity-settled share-based payments |
— |
|
|
— |
|
|
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 common 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 December 31, 2023 |
7,065,993 |
|
|
334,211,338 |
|
|
40,050,053 |
|
|
(286,127,819 |
) |
|
7,382,166 |
|
|
102,581,730 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
InflaRx N.V. and
subsidiariesConsolidated statements of cash
flows for the years ended December 31, 2023,
2022 and 2021
|
2023 |
|
|
2022 |
|
|
2021 |
|
|
|
(in €) |
|
Operating activities |
|
|
|
Loss for the period |
(42,667,529 |
) |
|
(29,484,611 |
) |
|
(45,630,059 |
) |
Adjustments for: |
|
|
|
Depreciation & amortization of property and equipment,
right-of-use assets and intangible assets |
567,780 |
|
|
596,597 |
|
|
669,434 |
|
Net finance income |
(2,240,566 |
) |
|
(2,753,255 |
) |
|
(2,004,757 |
) |
Share-based payment expense |
3,414,489 |
|
|
6,044,356 |
|
|
4,332,205 |
|
Net foreign exchange differences |
413,017 |
|
|
385,359 |
|
|
111,606 |
|
|
|
|
|
Changes in: |
|
|
|
Financial assets from government grants |
732,971 |
|
|
(732,971 |
) |
|
— |
|
Other assets |
7,825,182 |
|
|
(3,308,485 |
) |
|
(7,094,467 |
) |
Employee benefits |
297,518 |
|
|
(64,024 |
) |
|
(3,290 |
) |
Other liabilities |
2,738,164 |
|
|
9,403 |
|
|
19,863 |
|
Liabilities from government grants received |
(6,209,266 |
) |
|
(2,090,734 |
) |
|
8,300,000 |
|
Trade and other payables |
6,986,824 |
|
|
(3,586,706 |
) |
|
316,112 |
|
Inventories |
(11,367,807 |
) |
|
— |
|
|
— |
|
Interest received |
1,732,284 |
|
|
1,287,200 |
|
|
1,070,235 |
|
Interest paid |
(36,025 |
) |
|
(44,946 |
) |
|
(23,633 |
) |
Net cash used in operating activities |
(37,812,966 |
) |
|
(33,742,817 |
) |
|
(39,936,751 |
) |
Investing activities |
|
|
|
Purchase of intangible assets and property and equipment |
(81,100 |
) |
|
(162,391 |
) |
|
(37,778 |
) |
Purchase of current and non-current financial assets |
(104,051,972 |
) |
|
(64,474,543 |
) |
|
(97,516,417 |
) |
Proceeds from the maturity of current financial assets |
86,436,456 |
|
|
83,995,029 |
|
|
71,603,310 |
|
Net cash from/ (used in) investing activities |
(17,696,616 |
) |
|
19,358,095 |
|
|
(25,950,885 |
) |
Financing activities |
|
|
|
Proceeds from issuance of ordinary shares |
56,483,929 |
|
|
2,349,624 |
|
|
65,142,549 |
|
Transaction costs from issuance of ordinary shares |
(3,360,626 |
) |
|
(47,735 |
) |
|
(4,219,222 |
) |
Proceeds from exercise of share options |
236,943 |
|
|
— |
|
|
1,014,583 |
|
Repayment of lease liabilities |
(373,977 |
) |
|
(364,430 |
) |
|
(360,644 |
) |
Net cash from financing activities |
52,986,269 |
|
|
1,937,459 |
|
|
61,577,266 |
|
Net decrease in cash and cash equivalents |
(2,523,313 |
) |
|
(12,447,262 |
) |
|
(4,310,369 |
) |
Effect of exchange rate changes on cash and cash equivalents |
(974,099 |
) |
|
2,462,622 |
|
|
4,591,683 |
|
Cash and cash equivalents at beginning of period |
16,265,355 |
|
|
26,249,995 |
|
|
25,968,681 |
|
Cash and cash equivalents at end of period |
12,767,943 |
|
|
16,265,355 |
|
|
26,249,995 |
|
|
|
|
|
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 biotechnology
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, CFAVice President, Head of Investor RelationsEmail:
IR@inflarx.de |
Katja Arnold, Laurie Doyle, Dr. Regina LutzEmail:
inflarx@mc-services.eu Europe: +49 89-210 2280U.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 indication 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 MAA submission for vilobelimab and 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, the EMA 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.
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