InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical
company developing anti-inflammatory therapeutics by targeting the
complement system, announced today financial and operating results
for the year ended December 31, 2021.
Prof. Niels C. Riedemann, Chief Executive
Officer and Founder of InflaRx, commented: “We have made important
progress in broadening and advancing our development activities
over the course of 2021 and into 2022. This includes introducing a
new program, the oral small molecule C5aR inhibitor, INF904, and
moving vilobelimab into a new indication, cutaneous small cell
carcinoma. In addition, we reported promising results with
vilobelimab in pyoderma gangrenosum and ANCA-associated vasculitis,
and we now await the Phase III topline results in our COVID-19
trial. We are hopeful for a positive outcome but, either way, we
believe the results will help to further the overall understanding
of this devastating disease.”
He continued, “We are thankful for the corrected
advice letter from the FDA related to vilobelimab development in
hidradenitis suppurativa and will clarify our path forward in this
debilitating disease in the coming months. We expect a busy year
ahead as we work towards our goal of developing treatments to
control inflammation and improve the lives of patients suffering
from neutrophil-driven diseases.”
Recent Highlights and R&D
Update
Vilobelimab for Hidradenitis Suppurativa
(HS)
In February 2022, the Company received an advice
letter from the FDA related to its Phase III program and its IND.
The feedback to the clinical protocol indicated that the FDA
recommends using the Hidradenitis Suppurativa Clinical Response
Score (“HiSCR”) as the primary endpoint in the Phase III trial.
This FDA advice contrasted with the FDA advice provided to the
Company in a Type A meeting held in the third quarter of 2021.
In the minutes from that Type A meeting, FDA
provided advice on how to implement, name and validate the
meaningfulness of the modified HiSCR, a new primary endpoint
suggested by the Company, which would measure the reduction of all
three types of inflammatory lesions in HS–inflammatory nodules,
abscesses and draining tunnels. A reduction in draining tunnels is
not captured by the HiSCR. In these minutes, the FDA did not
recommend the traditional HiSCR as the primary endpoint measure.
Based on the advice received in the Type A meeting, InflaRx
announced in January 2022, the initiation of a Phase III program
designed to study patients with moderate to severe HS suffering
from actively draining tunnels. Because of the letter, InflaRx
paused activities related to the Phase III trial.
In March 2022, the Company received a corrected
advice letter from the FDA. The corrected letter states that the
FDA advice received by the Company in February 2022 “contains
errors.” In this corrected letter, the FDA no longer recommends
that the Company use the HiSCR as the primary endpoint for the
chosen patient population but gives recommendations related to
implementation of the modified HiSCR.
In light of this corrected advice from FDA,
InflaRx believes that further development in HS is feasible. Phase
III trial activities remain on hold while InflaRx evaluates next
steps for the program.
Vilobelimab in Pyoderma Gangrenosum
(PG) InflaRx previously initiated an open label,
multi-center Phase IIa exploratory study enrolling patients with
moderate to severe PG in Canada, the United States and Poland. The
study evaluated the safety and efficacy of vilobelimab in patients
with PG.
In October 2021, InflaRx announced preliminary
results from the third dosing cohort. At 2400mg biweekly, six of
the seven patients achieved clinical remission with a PGA score of
≤1, which reflects a closure of the target ulcer. All patients in
the third dosing cohort had elevated C5a levels at baseline that
were continuously suppressed after initiation of vilobelimab.
In August 2021, InflaRx also reported data for
ten evaluable patients in the first two dose cohorts at day 99. The
patient in the second dosing cohort demonstrating complete target
ulcer closure had been increased from the 1600mg dose group to the
highest dose of 2400mg dose on day 57 of the study, and the ulcer
closed after the dose escalation.
Final data will be presented as a late-breaker
oral presentation on March 26th at the American Academy of
Dermatology Association (AAD) Annual Meeting.
InflaRx plans to meet with the FDA this year to
discuss the design for a pivotal study.
Vilobelimab for Severe
COVID-19In October 2021, InflaRx announced full enrollment
in the Phase III part of the global Phase II/III trial evaluating
vilobelimab in mechanically ventilated patients with COVID-19. A
total of 369 patients across several countries, including in
Europe, South America and other regions, were enrolled. Topline
data for the 28-day mortality primary endpoint is expected to be
available by the end of March 2022. The results from this Phase III
trial will heavily influence our decision with respect to any
future development of vilobelimab in COVID-19 and the larger
strategic focus of the Company.
In October 2021, InflaRx announced that it had
received a grant of up to €43.7 million from the German Ministry of
Education and Research and the German Ministry of Health to support
the Company’s development of vilobelimab for the treatment of
severe COVID-19 patients. The initial tranche amounts to €25.8
million (approximately $29.9 million) and is structured as
reimbursement of 80% of certain pre-specified expenses related to
the clinical development and manufacturing of vilobelimab. The
remainder of the grant will be awarded in three additional
subsequent tranches, each conditional on reaching agreed-upon
development and manufacturing-related milestones for the preceding
tranche and structured as reimbursement for Company expenses.
Individual tranches will not be paid if the preceding milestone of
a tranche is not met. As of December 31, 2021, InflaRx had received
€8.3 million of this grant funding.
Vilobelimab for ANCA-associated
Vasculitis (AAV)In May 2021, InflaRx reported topline data
from the U.S. IXPLORE Phase II study of vilobelimab in AAV. The
results indicated that vilobelimab, when added to the current
standard of care, was well tolerated.
In November 2021, InflaRx reported topline data
from the European Phase II IXCHANGE study of vilobelimab in AAV.
The study achieved its principal objective, demonstrating
comparable clinical response of vilobelimab to standard of care,
while significantly reducing the need for glucocorticoid treatment
in this life-threatening indication.
The Company plans to discuss the data from the
U.S. and EU studies with regulatory authorities to determine next
steps with this program.
Vilobelimab for Cutaneous Squamous Cell
Carcinoma (cSCC) InflaRx is developing vilobelimab for the
treatment of PD-1/PD-L1 inhibitor resistant/refractory locally
advanced or metastatic cSCC. InflaRx previously initiated an open
label, non-comparative, two-stage, Phase II trial (NCT04812535) at
sites in Europe, the United States and elsewhere. The study is
investigating two independent arms: vilobelimab alone (Arm A) and
vilobelimab in combination with pembrolizumab (Arm B). The trial is
expected to enroll a total of approximately 70 patients.
In February 2022, the Company announced the
start of the second dosing cohort of Arm B. The interim analysis in
this arm, which is required to move to the second stage of the
Phase II trial, is expected after ten patients have been treated
and are evaluable for response assessment at the recommended Phase
II dose level, which will be selected based on data from the safety
run-in phase of the study. These data are expected to be available
in the first quarter of 2023.
In parallel, enrollment continues in the
monotherapy Arm A. Six patients are now enrolled in this arm. The
interim analysis in Arm A required to proceed to the second stage
is expected to be available after ten patients are evaluable for
response assessment. These data are expected to be available in the
third quarter of 2022.
INF904InflaRx announced in
January 2022 a new pipeline program, INF904, an oral small molecule
inhibitor of C5aR. InflaRx has been granted a composition of matter
patent for INF904 and associated compounds by the U.S. Patent and
Trademark Office and has completed IND-enabling (preclinical)
studies that demonstrated no obvious toxicological findings even in
the highest dose groups in required GLP toxicity analyses.
InflaRx expects to initiate a Phase I program in
the second half of 2022 and plans to study INF904 in
complement-mediated, chronic autoimmune and inflammatory diseases
where oral administration is the preferred choice for patients.
2021 Financial Highlights
Research and Development
Expenses
InflaRx’s research and development expenses
increased by €10.0 million in the year ended December 31, 2021
compared to the year ended December 31, 2020.
This increase is attributable to higher contract
research organization (CRO) and contract manufacturing organization
(CMO) costs from clinical trials in the amount of €8.4 million.
This increase was primarily due to higher expense for the Phase III
part of our COVID-19 trial and other running trials like Phase
II clinical program in patients with AAV, the Phase II clinical
program in patients with PG, the preparation of a Phase II clinical
program in patients cSCC and ongoing manufacturing activities for
clinical trial related materials.
In addition, a €1.5 million increase in
employee-related costs was mainly caused by a €1.0 million increase
in expenses from share-based compensation.
General and Administrative
Expenses
InflaRx’s general and administrative expenses
increased by €3.5 million to €12.0 million for the year ended
December 31, 2021, from €8.5 million for the year ended December
31, 2020. This increase is primarily attributable to a €2.2 million
increase in expenses from share-based compensation. Legal,
consulting and audit fees and other expenses increased by €0.5
million to €2.1 million for the year ended December 31, 2021,
mainly due to higher consulting and legal costs, mainly triggered
by SOX implementation. The increase of other expenses by €0.4
million is primarily related to higher D&O insurance cost.
Net Financial Result
InflaRx’s net financial result increased by €2.0
million in the year ended December 31, 2021 compared to the year
ended December 31, 2020. This net increase is mainly attributable
to higher foreign exchange income, which increased by €1.9 million
and lower foreign exchange expense, which decreased by €0.8
million. This effect was offset by lower interest income on
marketable securities, which decreased by €0.8 million.
Net Loss
InflaRx incurred a net loss of €45.6 million, or
€1.10 per common share, in the year ended December 31, 2021
compared to €34.0 million, or €1.3 per common share, in the year
ended December 31, 2020. As of December 31, 2021, the Company’s
total funds available were approximately €110.6 million,
composed of €26.2 million of cash and cash equivalents and
€84,4 million of financial assets.
Net Cash Used in Operating
Activities
InflaRx’s net cash used in operating activities
increased to €39.9 million in the year ended December 31, 2021,
from €36.5 million in the year ended December 31, 2020, mainly due
to the increase of research and development expenditures and higher
personnel costs.
Additional information regarding these results
and other relevant information is included in the notes to the
financial statements as of December 31, 2021 in “Item 18. Financial
Statements,” which are included in InflaRx’s most recent annual
report on Form 20-F as filed with the U.S. Securities and Exchange
Commission.
InflaRx N.V. and
subsidiaries
Consolidated Statements of Operations
and Comprehensive Loss for the Years Ended December 31, 2021, 2020
and 2019
in €, except for share information |
2021 |
|
2020 |
|
2019 |
|
|
|
|
Operating Expenses |
|
|
|
Research and development expenses |
(35,697,935 |
) |
|
(25,684,140 |
) |
|
(44,582,136 |
) |
General and administrative expenses |
(11,984,722 |
) |
|
(8,467,203 |
) |
|
(12,501,048 |
) |
Total Operating Expenses |
(47,682,657 |
) |
|
(34,151,343 |
) |
|
(57,083,184 |
) |
Other income |
54,221 |
|
|
221,748 |
|
|
400,253 |
|
Other expenses |
(6,381 |
) |
|
(13,209 |
) |
|
(85,242 |
) |
Operating Result |
(47,634,816 |
) |
|
(33,942,804 |
) |
|
(56,768,173 |
) |
Finance income |
109,391 |
|
|
887,702 |
|
|
2,840,676 |
|
Finance expenses |
(24,769 |
) |
|
(26,000 |
) |
|
(22,265 |
) |
Foreign exchange result |
1,964,135 |
|
|
(776,512 |
) |
|
694,944 |
|
Other financial result |
(44,000 |
) |
|
(126,000 |
) |
|
— |
|
Income Taxes |
— |
|
|
— |
|
|
— |
|
Loss for the Period |
(45,630,059 |
) |
|
(33,983,614 |
) |
|
(53,254,817 |
) |
|
|
|
|
Share Information |
|
|
|
Weighted average number of shares outstanding |
41,629,974 |
|
|
27,064,902 |
|
|
26,004,519 |
|
Loss per share (basic/diluted) |
(1.10 |
) |
|
(1.26 |
) |
|
(2.05 |
) |
|
|
|
|
|
|
|
|
Loss for the Period |
(45,630,059 |
) |
|
(33,983,614 |
) |
|
(53,254,817 |
) |
Other comprehensive income (loss) that may be reclassified to
profit or loss in subsequent periods: |
|
|
|
Exchange differences on translation of foreign currency |
6,777,061 |
|
|
(5,954,019 |
) |
|
2,177,033 |
|
Total Comprehensive Loss |
(38,852,998 |
) |
|
(39,937,633 |
) |
|
(51,077,785 |
) |
|
|
|
|
InflaRx N.V. and
subsidiaries
Consolidated Statements of Financial
Position as December 31, 2021 and 2020
in € |
2021 |
|
2020 |
|
|
|
ASSETS |
|
|
Non-current assets |
|
|
Property and equipment* |
274,373 |
|
|
408,263 |
|
Right-of-use assets* |
1,408,078 |
|
|
546,694 |
|
Intangible assets |
235,216 |
|
|
350,183 |
|
Other assets |
336,566 |
|
|
353,522 |
|
Financial assets |
27,206,990 |
|
|
272,268 |
|
Total non-current assets |
29,461,224 |
|
|
1,930,930 |
|
Current assets |
|
|
Current other assets* |
10,983,458 |
|
|
3,734,700 |
|
Income tax receivable* |
1,282,177 |
|
|
1,419,490 |
|
Financial assets |
57,162,266 |
|
|
55,162,033 |
|
Cash and cash equivalents |
26,249,995 |
|
|
25,968,681 |
|
Total current assets |
95,677,896 |
|
|
86,284,904 |
|
TOTAL ASSETS |
125,139,120 |
|
|
88,215,834 |
|
|
|
|
EQUITY AND LIABILITIES |
|
|
Equity |
|
|
Issued capital |
5,304,452 |
|
|
3,387,410 |
|
Share premium |
280,310,744 |
|
|
220,289,876 |
|
Other capital reserves |
30,591,209 |
|
|
26,259,004 |
|
Accumulated deficit |
(213,975,679 |
) |
|
(168,345,620 |
) |
Other components of equity |
3,050,270 |
|
|
(3,726,791 |
) |
Total equity |
105,280,996 |
|
|
77,863,880 |
|
Non-current liabilities |
|
|
Lease liabilities |
1,066,354 |
|
|
220,525 |
|
Other liabilities |
35,019 |
|
|
33,323 |
|
Total non-current liabilities |
1,101,373 |
|
|
253,847 |
|
Current liabilities |
|
|
Trade and other payables |
8,574,244 |
|
|
8,258,133 |
|
Liabilities from government grants received |
8,300,000 |
|
|
— |
|
Lease liabilities |
366,171 |
|
|
338,516 |
|
Employee benefits |
1,378,130 |
|
|
1,368,731 |
|
Other liabilities |
138,206 |
|
|
117,727 |
|
Provisions |
— |
|
|
15,000 |
|
Total current liabilities |
18,756,751 |
|
|
10,098,107 |
|
Total Liabilities |
19,858,124 |
|
|
10,351,954 |
|
TOTAL EQUITY AND LIABILITIES |
125,139,120 |
|
|
88,215,834 |
|
|
|
|
InflaRx N.V. and
subsidiaries
Consolidated Statements of Changes in
Shareholders’ Equity for the Years Ended December 31, 2021, 2020
and 2019
in € |
Issued capital |
|
Share premium |
|
Other capital reserves |
|
Accumulated deficit |
|
Other components of equity |
|
Total equity |
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2019 |
3,115,725 |
|
211,021,835 |
|
|
18,310,003 |
|
(81,107,188 |
) |
|
50,196 |
|
151,390,571 |
|
Loss for the Period |
— |
|
— |
|
|
— |
|
(53,254,817 |
) |
|
— |
|
(53,254,817 |
) |
Exchange differences on translation of foreign currency |
— |
|
— |
|
|
— |
|
— |
|
|
2,177,033 |
|
2,177,033 |
|
Total Comprehensive Loss |
— |
|
— |
|
|
— |
|
(53,254,817 |
) |
|
2,177,033 |
|
(51,077,784 |
) |
Equity-settled share-based payments |
— |
|
— |
|
|
6,832,210 |
|
— |
|
|
— |
|
6,832,210 |
|
Share options exercised |
16,905 |
|
(15,229 |
) |
|
— |
|
— |
|
|
— |
|
1,676 |
|
Balance as of December 31, 2019 |
3,132,631 |
|
211,006,606 |
|
|
25,142,213 |
|
(134,362,006 |
) |
|
2,227,228 |
|
107,146,673 |
|
Loss for the Period |
— |
|
— |
|
|
— |
|
(33,983,614 |
) |
|
— |
|
(33,983,614 |
) |
Exchange differences on translation of foreign currency |
— |
|
— |
|
|
— |
|
— |
|
|
(5,954,019 |
) |
(5,954,019 |
) |
Total Comprehensive Loss |
— |
|
— |
|
|
— |
|
(33,983,614 |
) |
|
(5,954,019 |
) |
(39,937,633 |
) |
Issuance of common shares |
234,982 |
|
9,535,961 |
|
|
— |
|
— |
|
|
— |
|
9,770,943 |
|
Transaction costs |
— |
|
(729,840 |
) |
|
— |
|
— |
|
|
— |
|
(729,840 |
) |
Equity-settled share-based payments |
— |
|
— |
|
|
1,116,791 |
|
— |
|
|
— |
|
1,116,791 |
|
Share options exercised |
19,797 |
|
477,149 |
|
|
— |
|
— |
|
|
— |
|
496,946 |
|
Balance as of December 31, 2020 |
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 |
|
|
|
|
|
|
|
|
|
|
|
InflaRx N.V. and
subsidiaries
Consolidated Statements of Cash Flows
for the Years ended December 31, 2021, 2020 and 2019
in € |
2021 |
|
2020 |
|
2019 |
|
|
|
|
Operating activities |
|
|
|
Loss for the Period |
(45,630,059 |
) |
|
(33,983,614 |
) |
|
(53,254,817 |
) |
Adjustments for: |
|
|
|
Depreciation & amortization of property and equipment,
right-of-use assets and intangible assets |
669,434 |
|
|
712,713 |
|
|
663,166 |
|
Net finance income |
(2,004,757 |
) |
|
40,810 |
|
|
(3,513,355 |
) |
Share-based payment expense |
4,332,205 |
|
|
1,116,791 |
|
|
6,832,210 |
|
Net foreign exchange differences |
111,606 |
|
|
(247,322 |
) |
|
(368,477 |
) |
Other non-cash adjustments |
— |
|
|
3,436 |
|
|
60,628 |
|
Changes in: |
|
|
|
Other assets |
(7,094,467 |
) |
|
(1,554,611 |
) |
|
(2,364,399 |
) |
Employee benefits |
(3,290 |
) |
|
355,545 |
|
|
235,500 |
|
Other liabilities |
19,863 |
|
|
8,960 |
|
|
(209,948 |
) |
Liabilities from government grants received |
8,300,000 |
|
|
— |
|
|
— |
|
Trade and other payables |
316,112 |
|
|
(4,155,529 |
) |
|
5,734,795 |
|
Interest received |
1,070,235 |
|
|
1,201,547 |
|
|
3,001,109 |
|
Interest paid |
(23,633 |
) |
|
(26,387 |
) |
|
(20,903 |
) |
Net cash used in operating activities |
(39,936,750 |
) |
|
(36,527,661 |
) |
|
(43,204,492 |
) |
Investing activities |
|
|
|
Purchase of intangible assets and property and equipment |
(37,778 |
) |
|
(94,189 |
) |
|
(594,889 |
) |
Purchase of non-current other financial assets |
— |
|
|
— |
|
|
(75,543 |
) |
Purchase of current and non current financial assets |
(97,516,417 |
) |
|
(101,600,176 |
) |
|
(82,547,409 |
) |
Proceeds from the maturity of current financial assets |
71,603,310 |
|
|
123,056,347 |
|
|
103,559,395 |
|
Net cash from/ (used in) investing activities |
(25,950,885 |
) |
|
21,361,982 |
|
|
20,341,554 |
|
Financing activities |
|
|
|
Proceeds from issuance of common shares |
65,142,549 |
|
|
9,770,944 |
|
|
— |
|
Transaction costs from issuance of common shares |
(4,219,222 |
) |
|
(729,841 |
) |
|
— |
|
Proceeds from exercise of share options |
1,014,583 |
|
|
496,946 |
|
|
1,676 |
|
Repayment of lease liabilities |
(360,644 |
) |
|
(366,156 |
) |
|
(296,020 |
) |
Net cash from/ (used in) financing activities |
61,577,266 |
|
|
9,171,893 |
|
|
(294,344 |
) |
Net increase/(decrease) in cash and cash equivalents |
(4,310,369 |
) |
|
(5,993,786 |
) |
|
(23,157,282 |
) |
Effect of exchange rate changes on cash and cash equivalents |
4,591,683 |
|
|
(1,168,813 |
) |
|
902,321 |
|
Cash and cash equivalents at beginning of period |
25,968,681 |
|
|
33,131,280 |
|
|
55,386,240 |
|
Cash and cash equivalents at end of period |
26,249,995 |
|
|
25,968,681 |
|
|
33,131,280 |
|
|
|
|
|
About Vilobelimab (IFX-1):
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, which is not the
case for molecules blocking the cleavage of C5. Vilobelimab has
been demonstrated to control the inflammatory response driven
tissue and organ damage by specifically blocking C5a as a key
“amplifier” of this response in pre-clinical studies. Vilobelimab
is believed to be the first monoclonal anti-C5a antibody introduced
into clinical development. Over 300 people have been treated with
vilobelimab in clinical trials, and the antibody has been shown to
be well tolerated. Vilobelimab is being developed for various
indications, including hidradenitis suppurativa, ANCA-associated
vasculitis and pyoderma gangrenosum, as well as severe COVID-19 and
cutaneous squamous cell carcinoma (cSCC).
About InflaRx N.V.:
InflaRx (Nasdaq: IFRX) is a clinical-stage
biopharmaceutical company focused on applying its proprietary
anti-C5a technology to discover and develop first-in-class, potent
and specific inhibitors of C5a. Complement C5a is a powerful
inflammatory mediator involved in the progression of a wide variety
of autoimmune and other inflammatory diseases. 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.
Jordan Zwick – Chief Strategy OfficerEmail:
IR@inflarx.deTel: +1 917-338-6523
MC Services AG
Katja Arnold, Laurie Doyle, Andreas
JungferEmail: inflarx@mc-services.euEurope: +49 89-210 2280US:
+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,” “believe,” “estimate,”
“predict,” “potential” or “continue” and similar expressions.
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 ongoing and planned
pre-clinical development and clinical trials, in particular our
Phase III trial in HS and related communications with the FDA, in
particular addressing the FDA’s advice in various communications to
us regarding the primary endpoint for the Phase III trial; the
impact of the COVID-19 pandemic on the Company; the timing and our
ability to commence and conduct clinical trials; potential results
from current or potential future collaborations; our ability to
make regulatory filings, obtain positive guidance from regulators,
and obtain and maintain regulatory approvals for our product
candidates; our intellectual property position; our ability to
develop commercial functions; expectations regarding clinical trial
data; our results of operations, cash needs, financial condition,
liquidity, prospects, future transactions, growth and strategies;
the industry in which we operate; the trends that may affect the
industry or us and the risks, uncertainties and other factors
described under the heading “Risk Factors” in InflaRx’s most recent
annual report on Form 20-F filed with the Securities and Exchange
Commission.
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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