InflaRx N.V. (Nasdaq: IFRX), a clinical-stage
biopharmaceutical company developing and commercializing
anti-inflammatory therapeutics by targeting the complement system,
announced today financial results for the three and six months
ended June 30, 2023 and provided an operating update.
“It was truly thrilling to launch Gohibic
(vilobelimab) for the treatment of certain critically ill COVID-19
patients in the United States and to be in the position of making
our drug available for patients in U.S. hospitals,” said Prof.
Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx.
“Our development work in other disease areas where C5a and C5aR may
play a significant role is progressing well as we strive to make
Gohibic (vilobelimab) available to other patients who may benefit
from it and to further our C5aR inhibitor INF904 into research in
additional disease areas. Today, we also announced first data from
an ongoing clinical trial in cutaneous squamous cell carcinoma.” He
continued: “With all the important work ahead, I am very pleased
that Dr. Camilla Chong has joined the team to drive our future
clinical development work with both vilobelimab and our oral C5aR
inhibitor INF904. With her impressive background in the
pharmaceutical industry, including her experience in launching new
pharmaceutical products, she will be instrumental in advancing our
complement-targeting therapies through the clinic and ultimately
into the market.”
Recent Highlights and Business
Update
Camilla Chong, M.D. joins InflaRx as
Chief Medical Officer:
Dr. Camilla Chong was appointed as Chief Medical
Officer, effective July 1, 2023. She is a medical doctor with 25
years of experience in the global pharmaceutical industry. Dr.
Chong has successfully led clinical development, medical affairs,
clinical operations, regulatory and pharmacovigilance teams and has
managed global clinical development programs. She has extensive
experience in the launch of many new pharmaceutical products in
multiple geographies. She joined InflaRx from Kyowa Kirin
Corporation, where she was Vice President and Global Medical
Affairs Therapy Area Head - Immunology. Dr. Chong is leading all
clinical development activities at InflaRx.
Commercial Launch of Gohibic
(vilobelimab) for the Treatment of Critically ill COVID-19 Patients
following the EUA in the United States:
In April 2023, the U.S. Food and Drug
Administration (FDA) issued an 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). Gohibic
(vilobelimab) has been commercially available to hospitals across
the United States since late Q2.
InflaRx is building an experienced and highly
focused commercial team to support the drug's launch and
distribution to hospitals. At the same time, the Company has set up
a robust supply chain to allow for uninterrupted supply of Gohibic
to the U.S. market. Lastly, InflaRx is raising awareness for this
treatment option in the medical community through dedicated medical
information campaigns.
Further, the Company is continuing discussions
with the FDA related to the submission of a Biologics License
Application (BLA) for a potential future full approval of Gohibic
(vilobelimab) in the United States. InflaRx has also completed
encouraging meetings with the rapporteur and co-rapporteur member
state teams of the European Committee for Medicinal Products for
Human Use (CHMP) related to a planned Marketing Authorization
Application with the European Medicines Agency (EMA). The Company
will provide updates on the status of regulatory submissions in the
United States and elsewhere once available.
Development of Vilobelimab in Pyoderma
Gangrenosum (PG):
In January 2023, InflaRx presented details
related to the design of its planned pivotal Phase III study with
vilobelimab in ulcerative PG, following compelling Phase II results
for the treatment of this rare neutrophilic and inflammatory skin
disease with destructive, painful cutaneous ulcers. The
multi-national, randomized, double-blind, placebo-controlled trial
has an adaptive design with an interim analysis that will determine
the planned total patient number. InflaRx submitted a Phase III
clinical trial protocol to the FDA, initiated the preparatory
activities and expects the first patient to be enrolled in Q3
2023.
INF904 – Low Molecular Weight, Oral C5aR
Inhibitor:
InflaRx is currently conducting a single (SAD)
and multiple ascending dose (MAD) Phase I clinical trial in healthy
volunteers to assess the safety, tolerability and pharmacokinetic /
pharmacodynamic properties of InflaRx’ new and proprietary low
molecular weight C5aR inhibitor INF904. The Company plans to show
the effect of INF904 on C5a-induced downstream activity and to
generate data in a format comparable with other published data on
C5aR inhibitory molecules like avacopan. Results from the SAD part
of the study are expected for Q3 2023 and results from the MAD part
of the study are expected in Q4 2023. In the future, InflaRx plans
to develop INF904 for complement-mediated, chronic autoimmune and
inflammatory diseases where oral administration is the preferred
choice for patients.
Initial Results for Development of
Vilobelimab in Cutaneous Squamous Cell Carcinoma:
InflaRx is conducting an open-label, multicenter
Phase II study, evaluating vilobelimab in two study arms - as
stand-alone therapy (Arm A) and in combination with pembrolizumab
(Arm B) - in patients with programmed cell death protein 1 (PD1) or
programmed cell death ligand 1 (PDL1) inhibitor
resistant/refractory, locally advanced or metastatic cutaneous
squamous cell carcinoma (cSCC). The main objectives of this trial
are to assess the safety and antitumor activity of vilobelimab in
the monotherapy arm and to assess the maximum tolerated or
recommended dose of vilobelimab and the safety and antitumor
activity of this drug pair in the combination arm.
An interim analysis of ten evaluable patients in
the monotherapy Arm A, which was not powered for significance due
to the small number of patients in this cohort, showed first
evaluable signals of efficacy: one patient had a complete response
and another patient displayed overall stable disease; and a third
patient showed stable disease of the target lesion according to
“Response Evaluation Criteria In Solid Tumors” (RECIST) criteria.
Vilobelimab treatment did not result in signals of concern related
to safety or tolerability in these patients with advanced cSCC, who
typically are of higher age and frequently suffer from multiple
comorbidities.
In Arm B, patients are currently being enrolled
and treated in the highest dose cohort. An interim analysis is
planned to be performed once ten patients in the highest dose
cohort are evaluable for response assessment. So far, six patients
have been enrolled, and the interim results are expected to be
available in H1 2024. The decision on whether to progress to stage
two of the study in arms A and/or B will be taken once the efficacy
analysis in Arm B has been completed.
Although generally, cSCC patients can be
effectively treated, some patients become resistant or refractory
to current treatment options. Those patients have very high
fatality rates and currently no approved treatment options. Based
on these first encouraging activity signals in this difficult to
treat patient population, the Company will decide on next
development steps once more results of the combination arm where
patients receive a PD-1 inhibitor in addition to vilobelimab become
available.
Financing Activities
In April 2023, the Company issued 3,235,723
ordinary shares under its ATM 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 and have a
nominal value of €0.12 per share. Aggregate proceeds from these
equity offerings amounted to €53.5 million after deducting
underwriting discounts.
On July 12, 2023, InflaRx filed a shelf
registration statement on Form F-3 with the U.S. Securities and
Exchange Commission (SEC) in order to replace its expiring shelf
registration statement and to authorize the issuance of up to $250
million in securities in registered offerings.
Dr. Thomas Taapken, Chief Financial Officer of
InflaRx, said: “It is an exciting time for InflaRx as we evolve
into a commercial-stage company and build a strong team to support
the commercialization of Gohibic. However, with the lower numbers
of severe COVID-19 cases, which we are grateful for, we are
expecting moderate demand and first revenues in H2 2023. Thanks to
our recent successful financing activities, we are well positioned
to invest in the necessary infrastructure to make Gohibic available
to hospitals across the United States, in addition to supporting
our clinical development activities, including the Phase III trial
with vilobelimab in pyoderma gangrenosum and the future development
of our promising C5aR inhibitor INF904. Despite a financial market
environment that has remained highly challenging, we are well
funded to support our operations well into 2026.”
Financial Highlights – Q2
2023
Research and Development
Expenses
Research and development expenses incurred in H1
2023 increased compared to the corresponding period in 2022 by €4.0
million. This increase was primarily due to higher third-party
expenses of €3.7 million related to manufacturing, development and
regulatory activities in conjunction with the EUA application for
vilobelimab in COVID-19.
General and Administrative
Expenses
General and administrative expenses in H1 2023
decreased by €1.6 million to €7.1 million from €8.7 million in H1
2022. This decrease was primarily attributable to decreasing
expenses associated with equity-settled share-based compensation
recognized in personnel expenses.
Sales and Marketing
Expenses
During H1 2023, InflaRx reported sales and
marketing expenses for the first time, which amounted to €0.3
million, as a result of the initiation of the commercialization of
Gohibic (vilobelimab). These expenses were mainly comprised of €0.1
million in personnel costs and €0.1 million in external
distribution services.
Other Income
Other income, which was primarily derived from
income from government grants, decreased by €1.8 million to €12.6
million for the first half of 2023, from €14.4 million for the
comparable period in 2022. The decrease was primarily due to the
absence of a non-recurring catch-up effect of costs incurred in
periods before Q2 2022, for which income recognition was deferred
until Q3 2022, when the recognition criteria were considered to be
met.
Net Financial Result
Net financial result decreased by €1.2 million
to €1.2 million for the six months ended June 30, 2023, from €2.4
million in the same period of 2022. This decrease was mainly
attributable to lower foreign exchange results which decreased by
€2.7 million, partly compensated by the increase in interest income
of €1.4 million due to increased interest payments from
marketable securities.
Net Loss
Net loss in H1 2023 amounted to €19.3 million,
compared to €13.5 million in H1 2022.
Net Cash Used in Operating
Activities
Net cash used in operating activities in H1 2023
decreased to €21.7 from €25.4 million in H1 2022.
Liquidity and Capital
Resources
As of June 30, 2023, the Company’s total
available funds were approximately €115.2 million, composed of
€19.5 million in cash and cash equivalents and €95.7 million in
marketable securities. These funds are expected to finance
operations at least into 2026.
Additional Financial
Information
Additional information regarding these results
and other relevant information is included in the notes to the
unaudited interim condensed consolidated financial statements as of
June 30, 2023, and the three and six months ended June 30, 2023,
and 2022, as well as the consolidated financial statements as of
and for the year ended December 31, 2022, in “ITEM 18. Financial
Statements,” in InflaRx’s Annual Report on Form 20-F for the year
ended December 31, 2022, as filed with the SEC.
InflaRx N.V. and
subsidiaries
Unaudited Condensed Consolidated
Statements of Operations and Comprehensive Loss for the three and
six months ended June 30, 2023 and 2022
|
For the
three months ended June 30, |
|
For the six
months ended June 30, |
|
2023 (unaudited) |
|
2022 (unaudited) |
|
2023 (unaudited) |
|
|
2022 (unaudited) |
|
(in €,
except for share data) |
|
|
|
|
|
Research and development expenses |
(10,919,595 |
) |
|
(11,180,958 |
) |
|
(25,651,503 |
) |
|
(21,652,881 |
) |
|
General and
administrative expenses |
(3,540,805 |
) |
|
(4,346,965 |
) |
|
(7,149,359 |
) |
|
(8,734,408 |
) |
|
Sales and
marketing expenses |
(276,051 |
) |
|
— |
|
|
(276,051 |
) |
|
— |
|
|
Other
income |
4,882,908 |
|
|
14,441,541 |
|
|
12,629,096 |
|
|
14,443,135 |
|
|
Other
expenses |
(2,624 |
) |
|
(279 |
) |
|
(3,190 |
) |
|
(844 |
) |
|
Operating Result |
(9,856,168 |
) |
|
(1,086,661 |
) |
|
(20,451,007 |
) |
|
(15,944,999 |
) |
|
Finance
income |
1,087,011 |
|
|
82,401 |
|
|
1,543,047 |
|
|
110,362 |
|
|
Finance
expenses |
(5,052 |
) |
|
(7,945 |
) |
|
(10,580 |
) |
|
(32,531 |
) |
|
Foreign
exchange result |
767,646 |
|
|
1,563,580 |
|
|
(369,664 |
) |
|
2,291,513 |
|
|
Other
financial result |
(195,567 |
) |
|
(86,000 |
) |
|
2,241 |
|
|
39,000 |
|
|
Income Taxes |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
Income (Loss) for the Period |
(8,202,130 |
) |
|
465,376 |
|
|
(19,285,963 |
) |
|
(13,536,654 |
) |
|
|
|
|
|
|
Share Information |
|
|
|
|
Weighted
average number of shares outstanding |
56,985,734 |
|
|
44,203,763 |
|
|
50,912,459 |
|
|
44,203,763 |
|
|
Income
(Loss) per share (basic/diluted) |
(0.14 |
) |
|
0.01 |
|
|
(0.38 |
) |
|
(0.31 |
) |
|
Other
comprehensive income (loss) that may be reclassified to profit or
loss in subsequent periods: |
|
|
|
|
Exchange
differences on translation of foreign currency |
(330 |
) |
|
4,408,940 |
|
|
(17,116 |
) |
|
5,718,815 |
|
|
Total Comprehensive Income (Loss) |
(8,202,460 |
) |
|
4,874,316 |
|
|
(19,303,079 |
) |
|
(7,817,839 |
) |
|
InflaRx N.V. and
subsidiaries
Unaudited Condensed Consolidated
Statements of Financial Position as of June 30, 2023 and December
31, 2022
|
June 30, 2023 (unaudited) |
|
December 31, 2022 |
|
|
(in
€) |
ASSETS |
|
|
Non-current assets |
|
|
Property and equipment |
296,382 |
|
328,920 |
|
Right-of-use
assets |
1,122,183 |
|
1,311,809 |
|
Intangible
assets |
90,789 |
|
138,905 |
|
Other
assets |
283,784 |
|
308,066 |
|
Financial
assets |
18,951,267 |
|
2,900,902 |
|
Total non-current assets |
20,744,405 |
|
4,988,602 |
|
Current assets |
|
|
Inventories |
578,705 |
|
— |
|
Current
other assets |
6,405,867 |
|
14,170,510 |
|
Current tax
assets |
2,925,037 |
|
1,732,087 |
|
Financial
assets from government grants |
5,193,246 |
|
732,971 |
|
Other
financial assets |
77,601,286 |
|
64,810,135 |
|
Cash and
cash equivalents |
19,515,959 |
|
16,265,355 |
|
Total current assets |
112,220,100 |
|
97,411,058 |
|
TOTAL ASSETS |
132,964,505 |
|
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 |
38,874,961 |
|
36,635,564 |
|
Accumulated
deficit |
(262,746,253 |
) |
(243,460,290 |
) |
Other
components of equity |
7,239,965 |
|
7,257,081 |
|
Total equity |
124,646,004 |
|
88,349,440 |
|
Non-current liabilities |
|
|
Lease
liabilities |
814,560 |
|
987,307 |
|
Other
liabilities |
36,877 |
|
36,877 |
|
Total non-current liabilities |
851,437 |
|
1,024,184 |
|
Current liabilities |
|
|
Trade and
other payables |
5,200,809 |
|
4,987,538 |
|
Liabilities
from government grants |
801,632 |
|
6,209,266 |
|
Lease
liabilities |
356,099 |
|
369,376 |
|
Employee
benefits |
900,474 |
|
1,312,248 |
|
Other
liabilities |
208,051 |
|
147,608 |
|
Total current liabilities |
7,467,065 |
|
13,026,036 |
|
Total Liabilities |
8,318,502 |
|
14,050,220 |
|
TOTAL EQUITY AND LIABILITIES |
132,964,505 |
|
102,399,660 |
|
InflaRx N.V. and
subsidiaries
Unaudited
Condensed Consolidated Statements of Changes in Shareholders’
Equity for the six months ended June 30, 2023 and
2022 |
(in
€) |
|
|
|
|
|
|
|
|
|
Issued capital |
|
Share premium |
|
Other capital reserves |
|
Accumulated deficit |
|
Other components of
equity |
|
Total equity |
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2023 |
5,364,452 |
|
282,552,633 |
|
|
36,635,564 |
|
(243,460,290 |
) |
|
7,257,081 |
|
|
88,349,440 |
|
Loss for the
period |
— |
|
— |
|
|
— |
|
(19,285,963 |
) |
|
— |
|
|
(19,285,963 |
) |
Exchange
differences on translation of foreign currency |
— |
|
— |
|
|
— |
|
— |
|
|
(17,116 |
) |
|
(17,116 |
) |
Total comprehensive loss |
— |
|
— |
|
|
— |
|
(19,285,963 |
) |
|
(17,116 |
) |
|
(19,303,079 |
) |
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 |
— |
|
— |
|
|
2,239,397 |
|
— |
|
|
— |
|
|
2,239,397 |
|
Share
options exercised |
14,431 |
|
222,512 |
|
|
— |
|
— |
|
|
— |
|
|
236,943 |
|
Balance as of June 30, 2023 |
7,065,993 |
|
334,211,338 |
|
|
38,874,961 |
|
(262,746,253 |
) |
|
7,239,965 |
|
|
124,646,004 |
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2022 |
5,304,452 |
|
280,310,744 |
|
|
30,591,209 |
|
(213,975,679 |
) |
|
3,050,271 |
|
|
105,280,996 |
|
Loss for the
period |
— |
|
— |
|
|
— |
|
(13,536,654 |
) |
|
— |
|
|
(13,536,654 |
) |
Exchange
differences on translation of foreign currency |
— |
|
— |
|
|
— |
|
— |
|
|
5,718,815 |
|
|
5,718,815 |
|
Total comprehensive loss |
— |
|
— |
|
|
— |
|
(13,536,654 |
) |
|
5,718,815 |
|
|
(7,817,839 |
) |
Equity-settled share-based payments |
— |
|
— |
|
|
4,668,481 |
|
— |
|
|
— |
|
|
4,668,481 |
|
Balance as of June 30, 2022 |
5,304,452 |
|
280,310,744 |
|
|
35,259,689 |
|
(227,512,333 |
) |
|
8,769,086 |
|
|
102,131,638 |
|
InflaRx N.V. and
subsidiaries
Unaudited Condensed Consolidated
Statements of Cash Flows for the six months ended June 30, 2023 and
2022
|
For the six
months ended June 30, |
|
2023 (unaudited) |
|
2022 (unaudited) |
|
(in
€) |
Operating activities |
|
|
Loss for the period |
(19,285,963 |
) |
|
(13,536,654 |
) |
Adjustments
for: |
|
|
Depreciation & amortization of property and equipment,
right-of-use assets and intangible assets |
293,328 |
|
|
300,870 |
|
Net finance income |
(1,165,044 |
) |
|
(2,408,345 |
) |
Share-based payment expense |
2,239,397 |
|
|
4,668,481 |
|
Net foreign exchange differences |
(23,953 |
) |
|
130,347 |
|
Changes
in: |
|
|
Financial assets from government grants |
(4,460,274 |
) |
|
(8,260,503 |
) |
Other assets |
6,295,975 |
|
|
611,843 |
|
Employee benefits |
(411,774 |
) |
|
(640,112 |
) |
Other liabilities |
60,443 |
|
|
(7,869 |
) |
Liabilities from government grants received |
(5,407,634 |
) |
|
(6,154,865 |
) |
Trade and other payables |
213,270 |
|
|
(661,741 |
) |
Inventories |
(578,705 |
) |
|
— |
|
Interest
received |
556,068 |
|
|
631,504 |
|
Interest
paid |
(10,777 |
) |
|
(32,039 |
) |
Net
cash used in operating activities |
(21,685,642 |
) |
|
(25,359,081 |
) |
Investing activities |
|
|
Purchase of
intangible assets, property and equipment |
(24,673 |
) |
|
(9,728 |
) |
Purchase of
current financial assets |
(83,071,163 |
) |
|
(47,031,216 |
) |
Proceeds
from the maturity of financial assets |
55,202,491 |
|
|
59,595,044 |
|
Net
cash from/(used in) investing activities |
(27,893,346 |
) |
|
12,554,101 |
|
Financing activities |
|
|
Proceeds
from issuance of common shares |
56,483,929 |
|
|
— |
|
Transaction
costs from issuance of common shares |
(3,360,626 |
) |
|
— |
|
Proceeds
from exercise of share options |
236,943 |
|
|
— |
|
Repayment of
lease liabilities |
(184,791 |
) |
|
(182,014 |
) |
Net
cash from/(used in) financing activities |
53,175,455 |
|
|
(182,014 |
) |
Net
increase/(decrease) in cash and cash equivalents |
3,596,467 |
|
|
(12,986,995 |
) |
Effect of
exchange rate changes on cash and cash equivalents |
(345,862 |
) |
|
2,153,152 |
|
Cash and
cash equivalents at beginning of period |
16,265,355 |
|
|
26,249,995 |
|
Cash
and cash equivalents at end of period |
19,515,959 |
|
|
15,416,152 |
|
|
|
|
About InflaRx
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 focused on applying its proprietary anti-C5a and C5aR
technologies to discover and develop and commercialize
first-in-class, potent and specific inhibitors of the complement
activation factor known as C5a and its receptor known as C5aR. C5a
is a powerful inflammatory mediator involved in the progression of
a wide variety of autoimmune and other inflammatory diseases.
InflaRx’ 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 settings. 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.
The COVID-19 related work described herein is
partly funded by the German Federal Government through grant number
16LW0113 (VILO-COVID). All responsibility for the content of this
work lies with InflaRx.
Contacts:
InflaRx N.V. |
MC
Services AG |
Email: IR@inflarx.de |
Katja Arnold, Laurie Doyle, Dr. Regina Lutz |
|
Email: inflarx@mc-services.eu |
|
Europe: +49 89-210 2280 |
|
U.S.: +1-339-832-0752 |
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, our ability to 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 United States or elsewhere; the success of our future clinical
trials for vilobelimab and any other product candidates and whether
such clinical results will reflect results seen in previously
conducted preclinical studies and clinical trials; the timing,
progress and results of 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 BLA 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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